Regulatory Affairs Manager - Medical Devices Job Cambridge area,Massachusetts USA,Healthcare

Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies for new product development, product modifications, and lifecycle management of Class II medical devices.
Provide regulatory guidance during product development to ensure compliance from concept through commercialisation.
Support regulatory planning, timelines, and prioritisation aligned with business and product development objectives.
Monitor, interpret, and communicate changes in FDA regulations, guidance documents, and applicable standards impacting Class II medical devices.

Regulatory Submissions & Compliance

Prepare, review, and manage FDA regulatory submissions for Class II medical devices.
Support regulatory agency interactions, (pre-submission meetings, responses to FDA questions, and post-market regulatory activities etc) under the direction of the Director of Regulatory Affairs.
Maintain product registrations, listings, and regulatory records.
Evaluate regulatory impact of design changes, labelling updates, manufacturing changes, and promotional materials in collaboration with cross-functional teams.

Cross-Functional Collaboration

Partner with Research & Development, Quality Assurance, Clinical, Manufacturing, Supply Chain, and Marketing to integrate regulatory requirements throughout the product lifecycle.
Collaborate with the Director of Regulatory Affairs to ensure consistent regulatory messaging and alignment across teams.
Provide regulatory input to design controls, risk management, change control, and post-market surveillance activities.
Deliver regulatory training and guidance as needed.

Quality & Documentation

Ensure regulatory documentation is accurate, complete, and maintained in compliance with Quality System Regulation and internal procedures.
Support internal audits, external audits, and inspections.
Contribute to continuous improvement of regulatory processes, templates, and best practices.

Required Qualifications

Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related technical field - advanced degree preferred.
7+ years of regulatory affairs experience in the medical device industry.
Demonstrated experience preparing and supporting submissions for Class II medical devices.
Strong working knowledge of FDA regulations, Quality System Regulation, and ISO 13485.
Proven ability to work collaboratively with senior leadership and cross-functional teams.
Excellent written, verbal, and organizational skills.

Preferred Qualifications

Regulatory Affairs Certification (RAC).
Experience supporting global regulatory submissions (e.g., EU MDR, Canada).
Experience with software-enabled, electrical, or electromechanical Class II medical devices.
Experience working in a regulated manufacturing environment.

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