Director of Regulatory & Medical Affairs (New Haven)

Job Title:Director of Regulatory and Medical Affairs
Location:Malvern, PA
Type:Direct Hire
Essential Duties/Responsibilities:

• Manage Regulatory and Medical Affairs SOPs to ensure full compliance with global regulatory requirements.
• Maintain current knowledge of changes to relevant global regulatory standards and manage implementation of those changes into company business processes.
• Work proactively cross-functionally to ensure new product development, new clinical indications, and post market activities comply with internal processes and global regulatory standards.
• Develop the strategy and manage the creation, review, and edit of documentation for US and OUS regulatory submissions.
• Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device listings.
• Support efforts in review and approval of product labeling, technical publications, and promotional materials, assuring regulatory requirements are met, safety warnings and precautions are adequate, and all product claims are properly supported.
• Oversee medical complaint handling, Safety Committee meetings, adverse event review and reporting globally.
• Perform duties as the main Regulatory Contact for FDA, Person Responsible for Regulatory Compliance, or “PRRC (per EU MDR), and other Regulatory Bodies including supporting audits, as applicable.
• Oversee and serve as alternative GUDID Coordinator and Label Data Entry User for GUDID/other UDI database data entry, as required.
• Provide input to ensure the training programs for company staff covers the relevant regulatory requirements.
• Other Duties as needed or required.

• Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, MDSAP and US/global UDI requirements, including UDI database entry requirements.
• Well-versed in post marked surveillance monitoring and reporting activities, including those for FDA and EU MDR.
• Strong organizational skills, self-directed, attentive to details, and able to multitask.
• Strong problem-solving skills and ability to deal with changing priorities.
• Success with developing strategies for clearance of new and expanded indications for use
• Excellent written, verbal, and presentation skills.Education and Experience:
• BS/BA degree, or equivalent, in life sciences related field.
• RAC certification.
• 15+ years Regulatory Affairs in medical device field with management responsibilities.
• Strong understanding and experience with US and global regulatory requirements for class II medical devices including but not limited to21 CFR 820, ISO 13485, ISO 14971, ISO 10991, EU MDR, and MDSAP.
• Direct experience with FDA and notified body audits and negotiations.

• Advanced Degree preferred.