Quality Assurance and Regulatory Affairs Specialist
NeilMed Pharmaceuticals, Inc. is an ISO certified company which manufactures Class I medical devices. The products are registered with the FDA and have the CE Mark approval. We are looking for a Quality Assurance & Regulatory Affairs Specialist to join our Corporate Headquarters in Santa Rosa, California. This is a fantastic opportunity for a highly motivated professional who is interested in joining the industry leader of Nasal, Sinus and Allergy care.
EMPLOYEE BENEFITS: NeilMed is willing to match your current company's salary program, which would include:
10% Salary Increase
Flexible Working Hours
2 weeks vacation
3 Sick days per year
6 Paid Holidays
The position supports the Quality and Regulatory efforts including national and international applications and handling for products, developing technical files to ensure regulatory compliance and assist in identifying medical device/ drugs regulations for various geographies. In addition, this position will work with the quality team to improve and maintain the Quality Management System and strategies to ensure regulatory and product standard compliance.
Summary of Responsibilities:
Support product registration and regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets. Assist the VP of QA/RA in developing and implementing quality strategies. Improve quality system / procedures to maintain compliance with ISO 13485:2003. Coordinate and support 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 support for quality systems improvements, and business process improvement initiatives.
- Support product's registration and regulatory submissions for new and existing products including FDA 510(k), Drugs Dossiers, Technical Files, Canadian Device License Applications, and internal "Letters to File".
- 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.
- Create and review 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, execute and complete 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.
- Create, review and approve test protocols (as needed) to support regulatory submissions and testing.
- Create and update Risk Management and provide input in design verification, design validation, shelf life studies.
- Investigate complaints, create reports and document them. Take action on reportable complaints.
- Conduct material qualification testing for all the new raw materials to be used for production.
- Manage and renew all the regulatory registrations.
- Support new products development projects.
- Collaborative, flexible and able to complete other assignments as needed.
KNOWLEDGE & EDUCATION
- Bachelor Degree in Science or equivalent; preferred Masters Degree.
- 2 to 3 years experience is preferred
- Knowledge of FDA medical device and drug 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 ISO13485 regulations
- Knowledge or experience in Risk management
- Knowledge of QS regulations preferred.
- Statistical analysis and problem-solving ability strongly preferred
- Proficient in timely review of technical and clinical data.
- Proficient in FDA and international regulations (EU and Canada)
- 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.
Walking up and down stairs, bending, and standing for periods of time, ability to lift 10 to 20 pounds of weight at times for occasional inspection.
NeilMed Pharmaceuticals is a family owned and operated global company that holds the leadership brand position for saline and nasal care products worldwide. NeilMed Pharmaceutical has offices and warehouses located in Canada, Australia, New Zealand, United Kingdom, Malaysia, Singapore, India and is rapidly expanding its sales in Southeast Asia and South America. Our success is attributed to the dedicated, passionate and committed employees that work at NeilMed, who are passionate about the company and their contributions toward the overall mission.
Santa Rosa, CA
Mon, 2 Oct 2017 15:01:06 PDT