Senior Manager, International Device Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the international regulatory strategy for high-risk implantable medical device initiatives, concentrating on Japan, China, and Latin America.

• Act as the regulatory point of contact for engagements with global regulators and certification authorities.

• Offer regulatory guidance throughout product development, design modifications, and post-market monitoring.

• Work alongside cross-functional teams to convert country-specific regulations into practical program strategies.

• Keep track of and evaluate changing international medical device regulations and facilitate the implementation of regulatory insights.

• Guide regulatory personnel and cross-functional teams, ensuring preparedness for inspections and effective leadership communication.

• Oversee the coordination of submissions and responses to deficiencies outside of the U.S.

• Guarantee adherence to international medical device marketing regulations.

• Represent Device Regulatory Affairs in regular interactions with health authorities.

⛳️ Requirements

• Bachelor's degree; an advanced degree is preferred.

• Over 7 years of experience in Regulatory Affairs for Class III implantable medical devices.

• Minimum of 5 years of experience with combination product implantable medical devices.

• Strong comprehension of international medical device regulations, particularly in Japan, China, and Latin America.

• Experience in cross-functional collaboration within a global framework.

• Proficient in managing regulatory strategies and submissions for intricate medical devices.

• Demonstrated leadership and mentoring skills.

• Exceptional communication and negotiation abilities.

🏝️ Benefits

• Regular employees qualify for short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Medical, Dental, Vision, and Life insurance coverage.

• Fitness and Wellness programs, including fitness reimbursement.

• Short- and Long-Term Disability insurance.

• A minimum of 15 days of paid vacation.

• Additional shutdown time off at the end of the year (Dec 26-Dec 31).

• Up to 12 paid holidays plus 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Engagement in Employee Resource Groups.