About the Role
The Principal Regulatory Affairs Specialist develops and executes regulatory strategies for medical device products, submissions, and lifecycle changes. This role provides hands-on regulatory support for new product marketing submissions, changes to existing devices, global registrations, audits, labeling, and ongoing compliance with applicable regulations and company standards.
What You'll Do
- Develop and execute regulatory plans for product submissions, including 510(k) Premarket Notifications, EU MDR Technical Documentation, Canadian Licensing Submissions, and select Japan/China submission content.
- Serve as the regulatory representative on cross-functional project teams throughout the product lifecycle, providing strategic guidance on global regulatory requirements.
- Prepare for and support communications with regulatory agencies and Notified Bodies, including FDA interactions, submission reviews, approvals, audits, and inspections.
- Maintain complete and current regulatory files, product registrations, and supporting documentation.
- Review device labeling, advertising, and promotional materials for compliance with approved submissions and applicable global regulations.
- Monitor new and changing regulations, assess business impact, and recommend appropriate compliance actions.
- Mentor junior regulatory staff and provide regulatory guidance to cross-functional partners.
What You'll Bring- Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical field.
- 7+ years of regulatory affairs experience in the medical device industry.
- Demonstrated experience preparing and supporting global regulatory submissions, including FDA 510(k), EU MDR/CE Marking, and Health Canada submissions.
- Strong understanding of FDA regulations, EU MDR, international regulatory frameworks, product lifecycle requirements, labeling review, and regulatory compliance practices.
- Experience leading or supporting FDA meetings, agency interactions, audits, inspections, and cross-functional regulatory strategy discussions.
- Excellent technical writing, communication, project leadership, analytical thinking, and stakeholder management skills.
Preferred Qualifications- Experience supporting Class II medical devices, global market expansion, or multi-region regulatory submissions.
- Experience mentoring regulatory professionals or leading regulatory workstreams without direct supervisory authority.
- Regulatory Affairs Certification or advanced degree in a relevant discipline.
Compensation & Total RewardsThe estimated base salary range for this position is $131,000-$143,000 annually. Actual compensation may vary based on relevant experience, skills, education, internal equity, and business needs. Bracco Medical Technologies also offers a comprehensive total rewards package, including health benefits, paid time off, company holidays, paid family leave, retirement savings, tuition reimbursement, and professional development opportunities.
Join UsIf you are a seasoned regulatory affairs professional who enjoys shaping global regulatory strategy, partnering across technical teams, and supporting meaningful medical technology innovation, we invite you to apply.
