Director - Quality Assurance and Regulatory Affairs
NeilMed Pharmaceuticals, Inc. is an ISO certified manufacturer of Class I medical devices. Our products are registered with the FDA and manufactured at our Corporate Headquarters in Santa Rosa, California. Due to expansion, we are looking for a Director - Quality Assurance & Regulatory Affairs to add to our quality team. The position is responsible for the development and implementation of the quality management system and strategies to ensure compliance with established standards and agency guidelines.
SUMMARY OF RESPONSIBILITIES:
Develop and implement QA strategies. Act as a Management Representative and implement quality system regulatory procedures and initiatives in to achieve compliance with ISO 13485:2012. 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.
- 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.
- 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 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 training / mentoring to other QA employees and cross-functional teams.
- Develop and implement departmental and divisional policies and procedures.
EDUCATION AND KNOWLEDGE
- Bachelor in Science (Preferred Bachelor in a technical field).
- 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
- Thorough knowledge of product development process, design control and Quality Systems.
- Strong technical knowledge of medical device products.
- 5+ years of Quality Assurance and Regulatory Affairs experience in manufacturing, preferably for the medical industry experience.
- Demonstrated success in managing quality systems
- Knowledge or experience in risk management
- Knowledge of quality standards and regulatory regulations preferred.
- Statistical analysis and problem-solving ability strongly preferred
SKILLS AND COMPETENCIES
- Proficient in timely review of technical and clinical data.
- Proficient in FDA and international regulations (EU and Canada)
- Technical knowledge of medical devices.
- Good presentation skills.
- Strong interpersonal skills and ability to influence all levels of people.
- Computer skills; MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel
- Strong written and oral communications skills
- Detail oriented and Self-motivated.
- Able to work in a team.
- Excellent negotiation skills
- 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
Sat, 2 Sep 2017 14:51:07 PDT