Regulatory Affairs Manager - Medical Devices

Medella Life; Cambridge (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating with cross-functional teams. The ideal candidate has over 7 years of experience in regulatory affairs, strong knowledge of FDA regulations, and a relevant degree. This position offers a dynamic work environment and the chance to influence product lifecycle management.

Qualifications

• 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.

Responsibilities

• Define and implement regulatory strategies for new product development.
• Manage FDA regulatory submissions for Class II medical devices.
• Partner with various departments to integrate regulatory requirements.

Skills

Regulatory strategy development

FDA regulations knowledge

Collaboration with cross-functional teams

Regulatory submissions preparation

Excellent communication skills

Education

Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related

Job description

• 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.