Director, RA & QA

Position Summary:

Reporting to the senior management team, the Director of Regulatory Affairs (RA) and Quality Assurance (QA) leads the RA & QA function in the company and is responsible for the day-to-day RA & QA operations, such as maintaining regulatory compliance and continuously improving the MEVION quality management system (QMS), as well as the overall QA & RA strategy and planning.

The Director of RA & QA is responsible for developing and executing a regulatory strategy to meet the company’s business needs and for defining and achieving the regulatory objectives of Mevion and the Mevion quality management system (QMS). The Director of RA& QA also oversees all QA activities in the organization that are required to produce quality medical devices, including all activities necessary to meet overall corporate quality objectives and comply with related laws, regulations, and standards. In partnership with the senior management team, the Director of RA & QA shall seek to develop a quality and results centric company culture that drives customer satisfaction, employee satisfaction, meaningful regulatory compliance, and continually improves operational excellence.

The Director of RA & QA will provide project execution and assistance, strategy, and accomplished performance towards all regulatory and quality project and process success, as well as reinforcing company policies, goals, and priorities to meet or exceed all organizational objectives.

The Director of RA & QA leads Regulatory Affairs, Quality Systems, Quality Engineering, Inspection (incoming, in-process, final release), Operations Quality Assurance and Supplier Quality teams providing cross-functional leadership to meet quality goals, company objectives, customer requirements, and to comply with pertinent laws and regulations.

This is a hands-on management role and as such the Director of RA & QA shall be expected to contribute as needed to assure reliable and ongoing success, as well as strategic RA & QA planning.

Essential Functions:

Regulatory

1. Have in-depth knowledge of current and new regulations, laws, standards, and other official enactments in the field of regulatory affairs that may apply to the company, including US FDA and EU MDD/MDR, and provide detailed analysis, official recommendations, and gap analyses for new or revised laws, rules, and regulations.

2. Ensure adequate compliance schemes associated with all regulatory compliance systems, as required by laws and regulations.

3. Provide guidance to RA/QA Engineers, Design Project Teams, and other relevant parties to facilitate the timely accomplishment of all regulatory objectives, strategies, and compliance requirements.

4. Author and coordinate regulatory product clearance and device license submissions.

5. Submit all establishment registration applications.

6. Prepare and submit 510(k), CE Marking, and other related regulatory filings.

7. Submit all medical device adverse and field corrective actions reports and recall notifications.

8. Participate and assist in all external audits and inspections as needed.

9. Work with Quality Team in obtaining and maintaining company applicable ISO and CE Certifications as needed.

10. Develop, document, and implement regulatory strategy for new technologies and product modifications.

11. Interface with FDA, CE, and other regulatory agencies regarding regulatory submission strategy and approval reviews, as per company marketing plans.

12. Establish and maintain a professional and credible image with US FDA, and other regulatory agencies.

13. Experience and knowledge with China NMPA regulations and China GMP a strong plus.

Quality

1. Publicize the Quality Policy of the MEVION QMS and promote applicable company culture.

2. Define Quantifiable Quality Objectives, as part of organizational strategic planning.

3. Routinely pursue more efficient and effective operations (continual improvement).

4. Assure the quality of products and services, by defining and implementing pertinent quality control tests and inspections and engineering change order support.

5. Management reporting and facilitating Quality System Management Reviews.

6. Ensure that all Quality System requirements are effectively established and maintained.

7. Create and maintain an adequate Quality System structure, including adequate quality system administrative systems.

8. Manage the Internal Quality Audit Program.

9. Provide for quality system training of all Mevion employees.

10. Coordinate the creation, execution, and validation of all change orders.

11. Initiate and maintain pertinent metrics, trending, and statistical analysis.

12. Ensure that effective risk management controls are in place and result in safe and effective products and services.

13. Collaborate with engineering to ensure adequate design controls are in place. Provide Quality Engineering support for each design team and effort.

14. Maintain knowledge of competitive technologies in addition to medical and technical developments related to the Company’s products.

Leadership:

1. Define and implement the vision and strategy for Regulatory Compliance and Quality Assurance for the company. Assure alignment to annual corporate objectives, brand strategies, changing legislation and regulatory expectations.

2. Execute the strategic vision and defined objectives for the RA & QA functions of Mevion, Annual Operating Plan objectives, and approved Change Orders (Corrective Action, Preventive Action, and Process Change Orders).

3. Identify and resolve competency gaps.

4. Monitor Project Management activities and assure performance meets expectations.

5. Provide strong change leadership, to assure regulatory and quality policies and priorities support the rapid growth of this young company.

Education, Training, and Experience:

1. Bachelor Degree or Master’s Degree in the Sciences, RA/QA, Operational Management, or Law, or equivalent work experience.

2. Minimum of fifteen (15) years of regulatory affairs and quality assurance experience in medical device or related industry.

3. Experience in complex and powered medical devices strongly preferred.

4. Familiarity with clinical environments of use. Radiation oncology experience highly desirable.

5. RAPS certification desirable.

6. First-hand and deep experience in drafting and submitting FDA 510(k) submissions and CE Technical Files with successful results and proven track records.

7. Consistent track record of maintaining and improving quality systems and achieving accreditations. MDSAP/QSR, EU MDD/MDR knowledge and experience required.

8. International experience in medical device quality system (e.g., China) desirable.

9. Working knowledge of cGMP and IEC standard compliance of medical devices desirable.

10. Experience executing a successful internal quality system audit program.

11. Frontline experience managing and hosting FDA inspections and external audits.

12. Experience in supporting new product development, design controls and V&V, and post-market surveillance and complaint handling of medical devices.

13. Experience as Management Representative desirable.

14. Demonstrated leadership, management, and team building experience and skills.

15. Independent and self-motivated. Capable of working effectively and efficiently under pressure and prioritizing. Committed and ambitious for long-term corporate and departmental success.

16. Excellent communication, organization, and project management skills.

17. A hands-on self-starter who can work at both strategic and tactical levels.

18. Attention to detail. Dependable and reliable.

19. Team player with the ability to work collaboratively with all levels of management and across functional boundaries to solve problems.

20. Proven track record of learning quickly, taking initiative, working proactively, being resourceful and flexible, and taking on additional responsibilities.

21. Be able to perform at a high level in a fast-paced, dynamic environment.

Physical and Environmental Considerations:

1. Must be able to sit and stand for long periods of time.

2. Must be able to walk through the factory environment safely.

3. Typical office and lab environments.

4. Must be able to use standard office equipment including laptop, copier, phone, etc.