Senior Manager, Regulatory Affairs

Responsibilities

• Lead the development and execution of global regulatory strategies and device classifications for the SWICC product portfolio.
• Drive U.S. submissions (e.g., 510(k), De Novo) and global filings for FDA Class I & II and EU MDR Class I, IIa, and IIb devices.
• Integrate regulatory requirements into product development, design controls, technical documentation, and risk management (ISO 14971).
• Serve as the primary regulatory interface with health authorities, including the FDA and EU Notified Bodies.
• Oversee technical documentation, submission readiness, and post-market compliance, including MDR reporting and field actions.
• Mentor and develop regulatory team members while fostering strategic thinking and subject-matter expertise.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
• 8–10+ years of progressive medical device regulatory experience.
• Demonstrated experience leading FDA Class I and II submissions (e.g., 510(k)).
• Proven experience with EU MDR (2017/745) Technical Documentation and conformity assessments.
• Direct experience with FDA inspections and interacting with EU Notified Bodies.
• Deep technical knowledge of 21 CFR 820/QMSR, 21 CFR 807, 803, 806, ISO 13485, and ISO 14971.

Preferred Qualifications

• RAC certification or equivalent.
• Experience interacting with Rest of World (ROW) competent authorities.

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiatives and Health Assistance Resources
• Life, Short-Term, and Long-Term Disability insurance
• Parental and Caregiver Leave
• Tuition Reimbursement

About the Company

Healthmark Industries Co., Inc. (part of Getinge) provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. We exist to make life-saving technology accessible for more people through innovation in intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing.