Job Description

Job Title: Regulatory Affairs Specialist

Location: Massachusetts, United States

Experience: 2 5 Years

About the Role

We are seeking a proactive and detail-driven Regulatory Affairs Specialist with medical device industry experience. This role will be responsible for preparing and managing global regulatory submissions, ensuring compliance with international medical device regulations (FDA, EU MDR, Health Canada, etc.), and supporting product development and commercialization across global markets.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for Class I, II, and III medical devices in line with FDA, EU MDR/IVDR, and other international requirements.

• Maintain compliance throughout the product lifecycle, including new registrations, renewals, technical file updates, and post-market surveillance.

• Partner with cross-functional teams (R&D, Quality, Clinical, Marketing, Manufacturing) to define and execute regulatory strategies for new products and changes.

• Monitor and interpret evolving global regulations, ensuring timely communication of impacts to stakeholders.

• Support Notified Body audits, FDA inspections, and internal quality system audits.

• Maintain and update regulatory files, product registrations, and submission trackers.

• Review labeling, IFUs, promotional materials, and packaging for compliance.

• Contribute to Design History Files (DHF), Technical Documentation, and Clinical Evaluation Reports (CER).

• Participate in risk management activities and product safety reviews.

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field (Master's or RAC certification is a plus).

• 2 5 years of regulatory affairs experience within the medical device industry.

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR (2017/745), and other relevant regulations/standards.

• Hands-on experience with 510(k)s, Technical Files, and international submissions (Canada, Australia, Japan, LATAM).

• Proficiency with regulatory document management systems and Microsoft Office Suite.

• Excellent communication, organizational, and project management skills.

• Ability to handle multiple projects and meet deadlines in a fast-paced environment.

Preferred Qualifications

• RAC (Regulatory Affairs Certification)

• Experience with eCTD or electronic submission systems

• Familiarity with UDI requirements and registration databases (EUDAMED, GUDID)

Job Tags

Work at office,

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