Sr Manager, International Device Regulatory Affairs

📋 Description

• Lead international regulatory strategies for high-risk implantable medical device programs, with
• Develop and manage country-specific regulatory plans, submission strategies, and lifecycle
• Serve as the regulatory lead for interactions with international health authorities, regulators
• Coordinate ex-U.S. regulatory submissions, deficiency responses, and related activities throughout
• Provide regulatory leadership during product development, design changes, commercialization, and
• Partner with Quality, Clinical, Medical Safety, global Regulatory Affairs, and other

🎯 Requirements

• 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
• Demonstrated experience developing and executing regulatory strategies and submissions for complex
• Experience working collaboratively within global, cross-functional organizations and translating

🎁 Benefits

• Base compensation range of $138,000–$184,500, with final salary determined based on factors
• Eligibility for short-term and long-term incentive opportunities, including cash bonuses and equity
• 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.