Leonid Group is privileged to be retained by one of our longest-standing clients, a major medical diagnostics and life sciences company to appoint a Regulatory Affairs Manager based in Boston, Massachusetts.
Role overview:
The Regulatory Affairs Manager will support global regulatory strategy and submissions for a portfolio of diagnostic products. This role will manage regulatory activities throughout the product lifecycle, including product development, submissions, registrations, labeling changes, and post-market compliance activities.
Key responsibilities:
- Develop regulatory strategies for new and existing diagnostic products.
- Manage FDA submissions, international registrations, and technical documentation.
- Assess regulatory pathways and requirements for global markets.
- Monitor regulatory changes and provide guidance to cross-functional teams.
- Support product launches, design changes, and compliance initiatives.
- Coordinate responses to regulatory agency inquiries.
Qualifications:
- Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
- 5–8 years of regulatory affairs experience within medical devices, diagnostics, or life sciences.
- Experience with FDA submissions and international regulatory requirements.
- Strong communication, stakeholder management, and project management skills.
Leonid Group Corporate Governance is a talent advisory firm that specialises in the placement of Legal, Compliance, Risk, ESG and Sustainability and Audit professionals on an international scale across the Americas, EMEA, and APAC. These are global disciplines with teams worldwide, and our network reflects this. We work with multinational corporations to help structure their departments with the best people, from the Global Chief Compliance Officer and General Counsel to the Compliance Analyst and Trade Compliance Specialist.