Director, Regulatory Affairs

job summary:

In this role, the Director will have the opportunity to develop, implement and lead both regional and international strategies for assigned projects with various cross-functional teams. You will execute regulatory strategies for the earliest possible approvals of the company’s regulatory applications at all stages of development and post-approval, provide guidance for, and contribute to, the development of documents for regulatory agencies (e.g., IDE/PMA/510k/EU submissions), as well as ensuring that they meet current regulatory requirements and industry standards, are high quality, consistent, complete, and approvable on the first review cycle. This position manages others within the Regulatory Affairs group.

Provide regulatory advice on US, EU, and global requirements

• Provide strategic regulatory input on both developmental and lifecycle
• Manage submission strategies for all structural intervention regulatory projects and prepare regulatory project plans and timelines
• Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
• Review documents for submission to ensure consistency with company and submission strategy and compliance with regulatory requirements
• Ensure and lead proper FDA interactions on key projects
• Support the preparation and conduct of Agency meetings as necessary to support regulatory filings
• Coordinate regulatory department meetings and perform other project management activities for the structural intervention RA department (goal setting, meeting minutes, routine submission tracking including regulatory commitments, deliverables, submission content, etc.).
• Interface with other functions of the company, including other members of the regulatory affairs team, quality assurance, clinical operations, clinical development, medical affairs, business development, and program management.
• Develops, monitors, and appropriately adjusts the annual budget for department cost center(s).
• Provides appropriate level of cross-functional and customer-oriented communications regarding the status of department and quality system operation, as well as product performance.
• Development of staff by setting an example, providing guidance, work direction, corrective action, and offering counsel.

EDUCATION AND EXPERIENCE:

REQUIRED: 

• • Bachelor’s Degree in Engineering, Sciences, or related discipline
  • 10+ years of related work experience in a similar role, including PMA approval experience and/or knowledge of FDA regulations, practices, and procedures.
  • 2+ years in a leadership/direct supervision role
  • Demonstrated experience building strategic partnerships to further departmental and organizational objectives.
• • Ability to work within a team environment and/or as a senior individual contributor leveraging and/or engaging others to accomplish projects within a fast-paced, matrixed environment.
  • Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
  • Proficient with MS Office (Word, Excel, Outlook)

PREFERRED: 

• • Advanced degree in Engineering, Sciences, or related discipline
  • Experience working with Class III medical devices
  • EU MDR submission experience