Administrative Assistant — QA/RA click here

JOB TITLE: Administrative Assistant — QA/RA DEPARTMENT:

GENERAL DESCRIPTION - DUTIES

SUMMARY OF RESPONSIBILITIES: NeilMed Pharmaceuticals, Inc. is looking for an ambitious administrative assistant to join our Santa Rosa Corporate Headquarters. This is a fantastic opportunity for a go-getter, and highly motivated administrative assistant, who is interested in joining the industry leader of sinus rinse in the North Bay. Under general supervision, this position assists the VP of Quality Affairs/Regulatory Affairs and supports the needs of the deptartment. The essential job functions are to perform a variety of clerical and administrative tasks.

KEY RESPONSIBILITIES: Assist in preparation of regulatory compliance documents, obtaining approvals and signatures on regulatory documents. Correspondence and follow up with external regulatory agencies such as, FDA, TUV, etc. Set up of department meetings and taking meeting minutes. Coordinates and arranges meetings, prepares agendas, reserves and prepares facilities and transcribes minutes of meetings Calendaring and maintenance of VP of Quality & Regulatory’s schedule. Assistance with travel arrangements. Running errands for quality department. Clerical support to Engineers. Special Projects. Typing memos, correspondence letters, filing, mailings, and other duties as assigned. Organizes and maintains file system and files correspondence and other records Creates and maintains database and spreadsheet files Other duties as assigned

QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION)

KNOWLEDGE/EDUCATION Minimum High School Diploma. Bachelors degree preferred. JOB EXPERIENCE: At least 5 years experience in an administrative capacity. Regulatory/QA/Manufacturing/Engineering industry experience is a PLUS! SKILLS/COMPETENCIES: Strong MS OFFICE (Outlook, Word, Excel, and PowerPoint) skills Must be proficient in use of general office equipment such as fax, scanning capabilities, copying, printers, conference media, and phones. Ability to type (45-50) words per minute with at least 95% accuracy. Ideal candidate will be self-motivated, enthusiastic, dynamic, detail oriented, and extremely organized. Ability to multi-task with strong attention to detail Strong flexibility to changing priorities and deadlines. Effective verbal and written communication skills. Must be willing to work weekends and flexible hours Strong interpersonal skills PHYSICAL REQUIREMENTS: Walking up and down stairs, bending, and standing for limited periods of time May be required to sit for long periods of time Extensive use of keyboard and phones May be required to lift to 25 lbs. COMPENSATION: Commensurate with experience. Email to jobs@neilmed.com with the subject line "Administrative Assistant – QA/RA"

QA/RA Manager click here

JOB TITLE: QA/RA Manager DEPARTMENT: QA/RA

GENERAL DESCRIPTION - DUTIES

POSITION PURPOSE: NeilMed Pharmaceuticals, Inc. is an ISO certified company which manufactures Class 1 medical devices. The products are registered with the FDA and have the CE Mark approval. We are looking for a highly experienced QA/RA Manager to join our Corporate Headquarters in Santa Rosa, California (north of San Francisco). This is a fantastic opportunity for a go-getter and highly motivated individual who is interested in joining the industry leader of nasal, sinus and allergy care. The purpose of this position is to improve and maintain the Quality Management System and regulatory strategies for maintaining compliance with established standards and agency guidelines. SUMMARY OF RESPONSIBILITIES: Assist the VP of QA/RA in developing and implementing regulatory strategies. Act as a Management Representative. Implement quality system regulatory procedures and initiatives in to achieve compliance with ISO 13485:2003. Coordinate and lead internal and external audit Maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements, and business process improvement initiatives. Responsible for creation, preparation, and achievement of regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets, typically for Class I and II products.

KEY RESPONSIBILITIES: Act as Management Representative for the company if it is required by the company. Oversee generation and review of documents used in good manufacturing practices; monitor audits of production and quality control areas. Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness. Create Installation Qualification, Operational Qualification and Performance Qualification protocol and reports. Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness. Manage non conformance, corrective action preventive actions and deviation. Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organizations. Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), Technical Files, Canadian Device License Applications, and internal "Letters to File". Support Regulatory submissions and on-going regulatory compliance for product development process. Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. Review and sign off on product and manufacturing changes for compliance with applicable regulations. Review and approve regulatory submissions and approvals, including design and manufacturing changes and labeling. Review and approve test protocols to support regulatory submissions. Oversee Risk Management and provide input in design verification, design validation, shelf life studies. Provide technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams. Develop and implement departmental and divisional policies and procedures. Supervise 1 – 2 direct reports Other duties as assigned

QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION)

KNOWLEDGE/EDUCATION Bachelor of Science in Mechanical Engineering; prefer masters degree. Knowledge of FDA medical device regulations, guidance, and import/exports requirements. Knowledge of European Medical Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.) Knowledge with medical device labeling and promotional requirements. Strong understanding of the quality system and regulatory affairs functions. Thorough knowledge of product development process, design control and Quality Systems. Strong technical knowledge of medical device (Class I & Class II) products. JOB EXPERIENCE: Minimum 5 years of QA / Regulatory Affairs medical industry experience. 1 to 2 years supervisory experience Demonstrated success in Quality and regulatory management. Knowledge or experience in Risk management Knowledge of QS regulations preferred. Statistical analysis and problem-solving ability strongly preferred Experience in 510(k) submission process. SKILLS/COMPETENCIES: Proficient in timely review of technical and clinical data. Proficient in FDA and international regulations (EU and Canada) Excellent managerial and organizational skills and abilities. Strong leadership and motivational skills with effective team building capabilities. Technical knowledge of medical devices. Good presentation skills. Excellent computer skills – proficiency with MS Office products Strong written and oral communications skills; strong technical writing skills. Detail oriented and self-motivated. Ability to write clear, concise, and well thought out technical documents. Able to manage moderately complex problems/projects by exercising independent decision making and analytical thinking skills Ability to work under minimal supervision and independently. Must be able to work in a timeline-driven environment. Email to jobs@neilmed.com with the subject line "QA/RA Manager"

Warehouse Manager click here

JOB TITLE: Warehouse Manager DEPARTMENT: Warehouse

GENERAL DESCRIPTION - DUTIES

SUMMARY OF RESPONSIBILITIES: NeilMed Pharmaceuticals, Inc. is looking for an experienced Warehouse Manager to join our Santa Rosa Corporate Headquarters. This is a fantastic opportunity for a go-getter and highly motivated individual who is interested in joining the industry leader of sinus rinse in the North Bay. The Warehouse Manager will have overall responsibility for the distribution and warehousing of all finished goods from NeilMed Pharmaceuticals, Inc. which includes picking, packaging and shipment of products and materials. This position involves managing all warehouse personnel. The position is also responsible for the monitoring of stock levels to best serve our customers, and promoting and maintaining a safe work environment.

KEY RESPONSIBILITIES: Manage the layout and set up of the warehouse for the appropriate storage of goods and supplies. Plan, organize and control warehouse’ over-all operations for several hundred SKUs of finished goods and raw materials inventory. Organize all activities & assign jobs accordingly for staff. "Hands-on" involvement in Receiving, Restock & Redistribution Responsible for planning, implementing and managing the Warehouse Management System (WMS). Manage stock control: the self-assured receipt, storage, retrieval and timely delivery of goods; shipment loading & transferring; document recording and data entry into system Supervise the activities of workers engaged in receiving, storing, testing, and shipping products or materials. Interview, select, and train warehouse and supervisory personnel. Plan, develop, and implement warehouse safety and security programs and activities. Prepare or direct preparation of correspondence, reports, and operations, maintenance, and safety manuals. Issue shipping instructions and provide routing information to ensure that delivery times and locations are coordinated. Confer with department heads to coordinate warehouse activities, such as production, inventory, records control, and purchasing. Review invoices, work orders, consumption reports, and demand forecasts to estimate peak delivery periods and to issue work assignments. Inspect physical conditions of warehouses, equipment, and order testing, maintenance, repair, or replacement as necessary. Inventory management including cycle counting & aisle checks; reconciling with WMS system. Implement cost reduction principles in all aspects of warehouse transactions and activities. Maintain housekeeping of warehouse and surrounding area.

QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION)

KNOWLEDGE/EDUCATION Minimum High School Diploma. Bachelors degree preferred. Knowledge of existing government regulations related to the warehouse maintenance JOB EXPERIENCE: Minimum 5 years experience in Warehouse/Inventory management/Bar coding 3 - 5 years supervisory experience SKILLS/COMPETENCIES: Bi-lingual (English/Spanish) preferred Computer literate with knowledge and experience with MS Outlook, MS Word, and strong MS Excel skills. Ability to work a flexible schedule including some nights and weekends. Strong mathematical (multiplication & division) skills without using a calculator. Excellent managerial and organizational skills and abilities. Strong leadership and motivational skills with effective team building capabilities. Knowledge of the safety and legal procedures for handling and receiving goods. Ability to effectively manage time and resolve crises. Must have demonstrated excellent oral/written communication skills, and interpersonal skills to support interaction with internal customers and other team members. Ability work in a fast paced / dynamic team environment. PHYSICAL REQUIREMENTS: Ability to stand, squat, climb, bend, kneel, stoop, walk, push, pull, crouch and crawl for long periods of time Ability to travel up and down stairs and ladders Ability to lift up to 60lbs on a regular basis Ability to work in high places and in tight spaces Email to jobs@neilmed.com with the subject line "Warehouse Manager"

Manufacturing Engineer click here

JOB TITLE: Manufacturing Engineer DEPARTMENT: Manufacturing

GENERAL DESCRIPTION - DUTIES

SUMMARY OF RESPONSIBILITIES: NeilMed Pharmaceuticals, Inc. is looking for an experienced Manufacturing Engineer to join our Santa Rosa Corporate Headquarters. This is a fantastic opportunity for a go-getter and highly motivated individual who is interested in joining the industry leader of sinus rinse in the North Bay. The Manufacturing Engineer position will develop and improve manufacturing methods, systems and processes to produce a high quality product at optimal cost. Act under general supervision of Engineering head on multiple assignments of moderate scope and complexity.

KEY RESPONSIBILITIES: Continuous Improvement and Cost Analysis: Continually improve manufacturing methods/systems and process/ product improvements to optimize product performance and reduce manufacturing costs. Identify and evaluate opportunities for improvement and make specific recommendations for adoption. Perform cost analyses to reduce or optimize product costs. Concurrent Engineering: Support new product development or existing product line extensions / modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. Production Support and Trouble Shooting: Provide engineering support to manufacturing operation on routine basis. Address product related issues arising on the production floor. Define and generate all required documentation in support of manufacturing products and processes. These include: Engineering protocols, FMECAs, reports, manufacturing instructions and procedures. Ensures compliance with GMP’s and internal protocol. Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations. Equipment and Fixturing: Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. Collaborate on design with suppliers to fulfill equipment and fixturing requirements. Qualification and Validation: Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Apply six sigma methodologies as appropriate.

QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION)

KNOWLEDGE/EDUCATION B.S. in Engineering or equivalent Accomplished in oral and written communication skills, including presentation skills Experience in interfacing with suppliers, engineers, architects and/or contractors effectively communicating requirements resolving conflicts and achieving objectives Knowledge of QSR / ISO13485 / EN 46002 / MDD JOB EXPERIENCE: Minimum of three to five (3-5) years in manufacturing environment or equivalent Experience in statistical analysis SKILLS/COMPETENCIES: Computer skills – Word, Excel and PowerPoint Statistical Knowledge Supervisory /Management skills. Communication, technical writing. Ability to work under minimal supervision and independently. Must be able to work in a timeline-driven environment. Ability to mentor and give work direction Ability to lift 25 to 50 lbs Solid interpersonal skills and ability to work in a team environment Email to jobs@neilmed.com with the subject line "Manufacturing Engineer"

Facilities and Equipment Maintenance Technician click here

JOB TITLE: Facilities and Equipment Maintenance Technician DEPARTMENT: Maintenance

GENERAL DESCRIPTION - DUTIES

SUMMARY OF RESPONSIBILITIES: NeilMed Pharmaceuticals, Inc. is looking for a skilled Maintenance Technician to join our Santa Rosa Corporate Headquarters. This is a fantastic opportunity for a go-getter, and highly motivated individual, who is interested in joining the industry leader of sinus rinse in the North Bay. Under general supervision, this position will perform all preventive, corrective and renovative maintenance of buildings, grounds, facilities, equipment, and property as assigned.

KEY RESPONSIBILITIES: Repairs and maintains machinery and mechanical equipment. Repairs and maintains physical structures of buildings and maintains grounds. Maintain operating condition of buildings and equipment, and able to complete duties with a hands on approach. Complete duties working alone from simple directions. Utilize knowledge of fundamental mechanical, electrical, carpentry, plumbing, or heating and cooling skills in performing assignments. Operate common hand or power tools. Perform equipment maintenance and maintains corresponding records. Maintain warehouse maintenance supplies. Take precautions to protect warehouse equipment against loss. Retain and review warehouse maintenance documents and reports Other duties as assigned

QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION)

At a minimum 2 to 3 years of related experience Preferably worked in regulated industry GED or higher degree preferred Be able to communicate in English and follow documented instructions Valid CA. Drivers License , and good DMV report Effective communication and reporting skills Must be able to manage time and set priorities Must be computer literate, organized and detail oriented Strong multi-tasking and problem-solving skills Bilingual (English and Spanish) preferred but not required. Ability to lift 25 to 50 lbs Must be willing to work weekends and flexible hours Email to jobs@neilmed.com with the subject line "Facilities and Equipment Maintenance Technician"

Trade Show Coordinator click here

JOB TITLE: Trade Show Coordinator DEPARTMENT:

GENERAL DESCRIPTION - DUTIES

SUMMARY OF RESPONSIBILITIES: NeilMed Pharmaceuticals, Inc. is looking for an experienced Trade Show Coordinator to join our Corporate Headquarters in Santa Rosa, California (north of San Francisco). This is a fantastic opportunity for a go-getter and highly motivated individual who is interested in joining the industry leader of nasal, sinus and allergy care. The Trade Show Coordinator will be responsible for ensuring that all aspects of a trade show event are well planned and run smoothly.

KEY RESPONSIBILITIES: Coordinate logistics for pharmaceutical, physician and consumer trade shows all over the world. Responsible for tracking and reporting for the individual trade show events. Maintain tradeshow schedule Arrange hotel, air and transportation for trade show staff. Collect, input, and disseminate trade show details to team members and other Marketing groups as needed. Register staff; select/order services and furnishings. Ensure proper visual display of product line within venue area and suggest/make changes as necessary Coordination between venue staff and corporate headquarters Develop, submit and maintain paperwork for required services for each trade show Coordinate preshow and post-show marketing efforts in limited areas in support of tradeshows and other events as needed. Arrange for the return of the booth and exhibitor material Various administrative duties in Corporate Office

QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION)

KNOWLEDGE/EDUCATION High school diploma or equivalent required; B.A. or B.S. strongly preferred. Must have knowledge of countries, cities, currencies and time zones in the United States and around the world JOB EXPERIENCE: Minimum 5 years prior trade show experience for a mid-size company SKILLS/COMPETENCIES: Type 40 wpm with a 95% accuracy Ability to calculate simple math and convert currencies without assistance of a calculator Ability to work a flexible schedule including an occasional weekend. Ability to actively manage multiple trade shows simultaneously Computer proficiency with Microsoft Office. Strong Excel skills Ability to excel in a rapidly changing environment. Strong interpersonal skills in dealing with co-workers. Strong presentation skills. Strong problem solving skills Must be a self-starter Strong organizational skills with the ability to handle multiple projects at once while completing quality work on a timely basis and ensuring urgent priorities are completed. Excellent attention to detail. Ability to communicate with precision and clarity. Strong and clear handwriting skills. Excellent project management skills, demonstrated ability to successfully multitask. Demonstrated ability to effectively coordinate all aspects of a high profile trade event. Occasional travel (2-3 times per year) Email to jobs@neilmed.com with the subject line "Trade Show Coordinator"

Trade Show Representative click here

JOB TITLE: Trade Show Representative (New York City) DEPARTMENT:

GENERAL DESCRIPTION - DUTIES

SUMMARY OF RESPONSIBILITIES: NeilMed Pharmaceuticals, Inc. is looking for an experienced Trade Show Representative to join our growing organization. This is a fantastic opportunity for an energetic, independent, and highly motivated individual who is interested in joining the industry leader of nasal, sinus and allergy care. The Trade Show Representative demonstrates NeilMed’s products and answers questions for the purpose of creating interest in the products at healthcare industry trade shows all over the world. This position requires extensive domestic and international travel to trade shows at various major metropolitan convention centers as well as resorts for smaller meetings. The Trade Show Representative will also be directly responsible for the promotion and the sale of NeilMed products to physicians, physician assistants, pharmacists, nurse practitioners, hospitals, and retail establishments.

KEY RESPONSIBILITIES: Demonstrate and explain NeilMed products and uses of the products. Provide product samples, coupons, informational brochures, and other incentives to persuade people to buy products. Keep areas neat while working, and return items to correct locations following demonstrations. Record and report demonstration-related information such as the number of questions asked by the audience and the number of coupons distributed. Sell products being promoted, and keep records of sales. Set up and arrange displays and demonstration areas to attract the attention of prospective customers. Suggest specific product uses to meet customers' needs. Transport, assemble, and disassemble materials used in presentations. Identify interested and qualified customers in order to provide them with additional information. Practice demonstrations to ensure that they will run smoothly. Call on customer healthcare professionals to inform and educate regarding current products/new products; explain characteristics associated with product; discuss topics such as dosage, use and effect of products and medicinal preparations Distribute samples (through clearly defined protocols) and marketing material of new products Record and track inventory levels of samples and associated literature Complete all required administrative duties, including but not limited to all daily /weekly reports, inventory reports and sampling documents

QUALIFICATION REQUIREMENTS (EXPERIENCE, TRAINING, SKILLS, EDUCATION)

KNOWLEDGE/EDUCATION Bachelors degree JOB EXPERIENCE: Requires at least 5 years of experience, attending and supporting trade show activity. 5 years of pharmaceutical and/or medical device sales experience Valid unrestricted Driver’s License with a clean driving record SKILLS/COMPETENCIES: Strong customer service skills Excellent verbal and written communication skills Mature, motivated professional with excellent work ethic and integrity A professional in demeanor and dress Strong proficiency in MS Office applications, including Word and Excel. Initiative to run with little or no supervision Must be extremely flexible and adaptable Motivation to juggle multiple tasks and prioritize appropriately Extensive daily and overnight travel required with no restrictions. Must have viable transportation to call on and visit healthcare professionals Must be able to work weekends and/or holidays when necessary Email to jobs@neilmed.com with the subject line "Trade Show Representative (New York City)"