Sr. Regulatory Affairs Specialist (Hybrid - Acton, MA)

About the Role

The Senior Regulatory Affairs Specialist will lead activities supporting domestic and international regulatory registrations and submissions, collaborating with Marketing, New Product Development, Manufacturing, and Engineering teams.

Responsibilities

• Support initiatives to ensure regulatory approval of medical devices in domestic and international markets.
• Provide regulatory affairs support for all aspects of product development, manufacturing, and clinical studies, including pre-market, post-market, and physician-initiated studies.
• Support ongoing compliance and corporate initiatives.
• Partner with Marketing and Development teams to support currently marketed products, including reviewing labeling, promotional materials, product changes, and documentation requiring government approval.
• Compile and submit documentation for marketing initiatives.
• Review marketing and sales promotional materials for regulatory impact, including:
  • Promotional materials for journals and other media.
  • Trade show booths and distributed materials.
  • Sales talking points.
• Review product packaging and labeling changes for regulatory impact, including:
  • US labels in English.
  • Translations with certified translators.
  • Vendor documentation, certification, and quality fitness.
• Represent Regulatory Affairs on project teams and in key meetings regarding labeling and promotion.
• Assist with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and Rest of World registrations).
• Prepare submissions and reports for the FDA and other international agencies.
• Review submission decisions and content issues with management.
• Assist in planning, creating, organizing, and interpreting regulatory documents for submission.
• Review and approve project documentation such as specifications, procedures, schedules, test protocols, reports, and validations.
• Evaluate, communicate, and present change assessments to ensure timely compliance.
• Review, evaluate, and approve Engineering Change Orders (ECOs), especially for significant changes.
• Perform other duties as required.

Requirements

• Bachelor’s degree (B.S./B.A.) or equivalent combination of education and experience.
• Minimum of 5+ years of regulatory experience in the medical device industry.
• RAC Certification preferred.
• Knowledge of domestic and international regulatory guidelines and requirements.

Skills

• Effective verbal and written communication skills.
• Experience reviewing ECOs, requirements, and specification documents.
• Understanding of 21 CFR 820, CMDR, ISO 13485, and MDD.
• Team player with a focus on patient safety as the top priority.
• Ability to communicate at multiple levels of an organization.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint), Visio, and Project.
• Ability to organize and manage multiple priorities.
• Strong record-keeping and documentation skills.

Schedule

This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.

Pay

For U.S.-based positions, the annual base salary range for this role is $91,700.00 - $137,525.00. This position may also be eligible for incentive compensation.

Benefits

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