Director, Regulatory & Quality Affairs

The Director of Regulatory & Quality Affairs will be a critical team member supporting MDC's regulatory and Quality Affairs business and support client RA/QA strategy and regulatory submissions. The primary role and responsibilities include managing RA/QA business and personnel, and the development of regulatory strategies. submissions, and communicating with clients and regulatory bodies. The Director collaborates closely with MDC's executive management team to ensure the growth and success of the company's RA/QA business.

Responsibilities

• Direct and coordinate MDC’s Regulatory Affairs activities
• Collaborate with other MDC departments including Clinical Affairs and Quality Systems to ensure continuity of service across client projects
• Support business development secure new clients and project
  • Participate in client meetings and assist with developing project scope of work, resource requirements, and pricing for client proposals
• Directly engage in client projects to provide:
  • Regulatory guidance and strategy
  • Develop regulatory submissions including FDA registration & listings, 510(k), de novo, Pre-Market Authorization (PMA) and submissions to Notified Bodies under IVDR.
  • Develop strategy and actively engage with regulatory bodies to achieve approval of all submissions and filings
• Ensure department activities and resources associated with filings are dedicated to meeting client expectations 
• Implement systems to support continual improvement of Regulatory Affairs services and support long-term growth of the business
• Recruit, hire, train and coach Regulatory Affairs staff and team members
• Develop and achieve Regulatory Affairs department Long-Range Plans and annual Objectives and Key Results (OKRs)
• Participate in monthly management team meetings and provide regular updates on department LRP and OKRs progress
• Assist with developing and achieving MDC’s Corporate LRP and OKRs

Qualifications

• Bachelor’s degree in a scientific discipline; Master of Science or PhD a plus
• Minimum of 10 years of experience in Regulatory Affairs related to development of medical devices/IVDs.
• Experience with leadership responsibilities for numerous projects and functioning as primary contact for regulatory bodies (i.e., FDA) and clients.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesses strong written and verbal communication and presentation skills.
• Experience developing and/or reviewing regulatory submissions to the US FDA and/or experience with international regulatory affairs and the regulatory bodies governing them.
• Strong research, analytical and problem-solving skills.
• Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently.
• Must be punctual, polished, and professional.
• Ability to lead a team and mentor junior Regulatory Team members.
• Strong professionalism with customer relations and managing client relationships

About MDC

For over 35 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients around the world. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local communities’ health. Learn more at www.mdcassoc.com.

By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone, and know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.

Travel Requirements

15-25% Travel including local, within U.S and outside of the US. Travel may include:

• Attending off-site client meetings o Attending clinical Site Initiation Visits
• Attending FDA Meetings (i.e: Pre-Submission Meeting, Submission Issue Meetings, etc.)
• Attending annual industry conferences 

Pay & Benefits:

• Salary + Bonus
• 401(k) w/ match
• Equity incentive program
• Medical, Dental, and Vision Insurance
• Flexible Spending / Dependent Care Accounts
• STD/LTD/GTL/VTL
• Generous PTO / Sick time policy

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