Senior Regulatory Affairs Specialist

Diabetes Youth Families

Senior Regulatory Affairs Specialist coordinating both domestic and international regulatory activities for medical devices. Ensuring compliance and collaborating with various departments to support product development.

Posted 7/15/2026full-timeActon • California, Massachusetts • 🇺🇸 United StatesSenior💰 $91,700 - $137,525 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices, including pre-market and post-market processes, while ensuring compliance with domestic and international guidelines. Strong collaboration with marketing and development teams to support product initiatives and promotional materials.

Highest-signal resume keywords

Regulatory Affairs SupportMedical Device Industry ExperienceRAC CertificationRegulatory Guidelines KnowledgeDocumentation Compilation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Approval ProcessesProduct Development SupportClinical Study SupportMarketing Initiative DocumentationPromotional Material Review

Certifications & Qualifications

RAC Certification

Industry Keywords

Medical DevicesRegulatory GuidelinesDomestic MarketsInternational MarketsPost-Market Studies

About the role

Key responsibilities & impact

Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets.
Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies.
Partner with Marketing and Development teams to provide support to currently-marketed products as necessary.
Compile and submit documentation as required in support of marketing initiatives.
Review marketing and sales promotional materials for regulatory impact, including: Promotional materials for journals and other media, Trade show booths, materials for distribution, Sales talking points, etc.
Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion.

Requirements

What you’ll need

B.S. / B.A. or equivalent combination of education and experience.
5+ years of regulatory medical device industry experience.
RAC Certification preferred.
Knowledge of regulatory guidelines and requirements (domestic and international).

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs