Position Summary:

The Sr. Regulatory Affairs Specialist will be a key member of the Regulatory Affairs team, responsible for ensuring compliance with global regulatory requirements for Class III and Class II medical devices. This role involves developing and executing regulatory strategies, preparing submissions, and maintaining compliance with applicable regulations. The ideal candidate will have a proven track record in regulatory affairs within the medical device industry, strong communication skills, and the ability to work collaboratively in a fast-paced environment.

Key Responsibilities:

• Develop and implement regulatory strategies to support product approvals and lifecycle management for Class III and Class II medical devices.
• Provide regulatory guidance to cross-functional teams during product development and commercialization.
• Prepare, compile, author, and submit regulatory documentation to FDA, EU MDR, and other international regulatory bodies, including 510(k), PMA, Technical Files, and CE Marking.
• Manage responses to regulatory agency inquiries and audits.
• Ensure compliance with applicable global regulations and standards, including FDA, ISO 13485, and EU MDR.
• Maintain regulatory files and records in accordance with company and regulatory requirements.
• Partner with R&D, Quality, Clinical, and Marketing teams to ensure regulatory requirements are integrated into product development and post-market activities.
• Provide training and support to internal teams on regulatory requirements and processes.
• Monitor regulatory changes and assess their impact on existing products and processes.
• Support adverse event reporting, field actions, and product recalls as needed.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field (Master’s degree preferred).
• Minimum of 5-7 years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of regulatory requirements for Class III and Class II medical devices, including FDA, ISO 13485, EU MDR, and other international regulations.
• Proven experience with regulatory submissions (e.g., 510(k), PMA, Technical Files).
• Excellent communication, organizational, and project management skills.
• Ability to work independently and collaboratively in a team environment.
• RAC (Regulatory Affairs Certification) is a plus.