Sr Manager, International Device Regulatory Affairs
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Manager, International Device Regulatory Affairs based in the United States.
This leadership role will shape regulatory strategy for high-risk implantable medical device programs across international markets.
You will lead regulatory planning and execution across Japan, China, and Latin America, supporting successful market access and ongoing compliance.
The position offers broad exposure to product development, design changes, submissions, and post-market activities.
You will serve as a key regulatory representative in interactions with health authorities, certification bodies, and regional partners.
Working across Quality, Clinical, Medical Safety, and global regulatory teams, you will translate complex requirements into actionable strategies.
You will also contribute to regulatory intelligence, inspection readiness, and the development of regulatory talent.
This is an opportunity to influence global device programs while operating in a collaborative, cross-functional environment.
Accountabilities
Lead international regulatory strategies for high-risk implantable medical device programs, with primary focus on Japan, China, and Latin America.
Develop and manage country-specific regulatory plans, submission strategies, and lifecycle maintenance activities to support timely market access.
Serve as the regulatory lead for interactions with international health authorities, regulators, certification bodies, and in-country representatives.
Coordinate ex-U.S. regulatory submissions, deficiency responses, and related activities throughout the product lifecycle.
Provide regulatory leadership during product development, design changes, commercialization, and post-market surveillance activities.
Partner with Quality, Clinical, Medical Safety, global Regulatory Affairs, and other cross-functional teams to incorporate country-specific requirements into program plans.
Monitor evolving international medical device regulations and translate regulatory intelligence into practical business and program strategies.
Ensure compliance with applicable international medical device marketing and regulatory requirements.
Represent Device Regulatory Affairs in routine health authority interactions and provide clear regulatory guidance to internal stakeholders.
Mentor regulatory professionals and cross-functional colleagues while supporting inspection readiness and effective leadership communications.
Bachelor’s degree required; an advanced degree is preferred.
7+ years of Regulatory Affairs experience within Class III implantable medical devices.
At least 5 years of experience working with combination-product implantable medical devices.
Strong knowledge of international medical device regulatory frameworks, particularly those applicable to Japan, China, and Latin America.
Demonstrated experience developing and executing regulatory strategies and submissions for complex, high-risk medical devices.
Experience working collaboratively within global, cross-functional organizations and translating regulatory requirements into actionable plans.
Proven leadership and mentoring capabilities, with the ability to influence stakeholders across functions and regions.
Excellent written and verbal communication, negotiation, and relationship-management skills.
Strategic thinking, attention to detail, adaptability, resilience, and the ability to navigate complex regulatory environments.
Base compensation range of $138,000-$184,500, with final salary determined based on factors including skills, experience, location, and internal equity.
Eligibility for short-term and long-term incentive opportunities, including cash bonuses and equity incentives, based on individual and organizational performance.
Medical, dental, vision, and life insurance coverage.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation, plus additional year-end shutdown time off from December 26-31.
Up to 12 company-paid holidays, plus 3 paid days off for personal significance.
80 hours of paid sick time per calendar year.
Paid maternity and parental leave.
401(k) participation with company matching contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Opportunities to participate in Employee Resource Groups and an inclusive workplace community.