Senior Regulatory Affairs Specialist

BioTalent; Massachusetts; On-site; USD 120,000 - 150,000; Full time

Job summary

BioTalent in Massachusetts is seeking a Senior Regulatory Affairs Specialist to lead and execute regulatory strategies for complex Class III medical devices, collaborating with Clinical, Quality, R&D and Manufacturing teams in a fast-paced, growth-oriented environment.

The role centers on leading FDA submissions (including PMAs), global registrations, and guiding design controls, risk management, and product commercialization throughout development.

Qualifications

• Bachelor's degree in a scientific or engineering discipline.
• 5+ years of medical device Regulatory Affairs experience.
• Strong experience with PMA submissions and Class III devices.
• Proven ability to lead submissions while remaining hands-on in authoring and execution.
• Strong understanding of FDA regulations and product development processes.

Responsibilities

• Develop and execute regulatory strategies for Class III medical devices.
• Lead and author FDA and global regulatory submissions, including PMAs and supplements.
• IDE submissions and amendments.
• Global registrations and post-approval submissions.
• Serve as the regulatory lead on cross-functional product teams.
• Assess regulatory impact of product changes and development activities.
• Provide regulatory guidance related to design controls, risk management, clinical activities, and product commercialization.
• Support interactions with FDA and other regulatory authorities.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional work

Authoring documents

Education

Bachelor's degree in science/engineering

Job description

Our client, an innovative medical device company, is seeking a Senior Regulatory Affairs Specialist to support regulatory strategy and submissions for complex Class III products.

This is a hands-on role for a regulatory professional who can both lead and execute. The successful candidate will drive key submission activities while working closely with Clinical, Quality, R&D, and Manufacturing teams in a fast-paced, growth-oriented environment.

Responsibilities

• Develop and execute regulatory strategies for Class III medical devices.
• Lead and author FDA and global regulatory submissions, including:
• PMA applications and supplements
• IDE submissions and amendments
• Global registrations and post-approval submissions
• Serve as the regulatory lead on cross-functional product teams.
• Assess regulatory impact of product changes and development activities.
• Provide regulatory guidance related to design controls, risk management, clinical activities, and product commercialization.
• Support interactions with FDA and other regulatory authorities.

Qualifications Required

• Bachelor's degree in a scientific or engineering discipline.
• 5+ years of medical device Regulatory Affairs experience.
• Strong experience with PMA submissions and Class III devices.
• Proven ability to lead submissions while remaining hands-on in authoring and execution.
• Strong understanding of FDA regulations and product development processes.

Preferred

• Experience with electrophysiology, cardiology, catheter-based, or other electro-medical devices.
• Global regulatory submission experience.
• Knowledge of Quality Systems, Design Controls, and Risk Management.
• Experience in a small or growth-stage medical device company.
• RAC certification.

What We're Looking For

• Self-sufficient and highly accountable.
• Comfortable working in a fast-moving environment with shifting priorities.
• Strong collaborator with a roll-up-your-sleeves mentality.
• Able to balance strategic thinking with day-to-day execution.