Regulatory Affairs Specialist

Responsibilities

Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the FDA.

• Determine and document change assessments for EU Class III & IIb devices to ensure compliance with the EU Medical Device Regulation.
• Plan and prepare submissions for EU Class III & IIb devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the Notified Body.
• Support submission and maintenance of product registrations in markets worldwide.
• Support product registrations, including creating, revising, reviewing and compiling documents for submission to regulatory authorities, as well as assisting in responding to questions and requests from such authorities.
• Assist in external audits by supporting responses to auditor questions and requests.
• Keep abreast of new or changed regulations and standards and perform gap analyses.
• Perform additional duties as assigned.

• (REQUIRED) Bachelor’s degree, preferably in the life sciences; advanced degree a plus.
• (REQUIRED) At least 3 years of experience in medical device field, including hands-on experience with submissions.
• Experience in regulatory submissions to medical device regulatory bodies a plus; e.g., FDA, Health Canada, ANVISA/INMETRO, EU NB, MHRA, Swiss medic, NMPA, PMDA, MFDS, and TGA.
• Experience with software-driven and electro-mechanical medical devices a plus.
• Strong knowledge of US and international requirements for regulatory submissions and maintenance of medical devices.
• Team player with ability to work independently in hybrid/in-person setting (Bedford, MA).
• Excellent and effective written and verbal communication skills.
• Excellent interpersonal skills, good judgment and analytical skills.
• Effective time management and organizational skills.
• Consistent, quality work and commitment to follow-through.