With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Senior Manager, Regulatory Affairs
Location
United States
Posted
10 days ago
Salary
$161.9K - $202.4K / year
Seniority
Lead
No structured requirement data.
Job Description
Senior Manager, Regulatory Affairs
Getinge
Role Description The Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio. - Ensures consistent compliance with U.S. (FDA), EU MDR (2017/745), and applicable global regulations. - Collaborates with product development, quality, operations, marketing, clinical affairs, and global regulatory teams. - Serves as a primary point of regulatory accountability for cross-functional leadership engagement and health authority interactions. Qualifications - Must have FDA and Notified Body Audit Experience. - Deep technical knowledge of 21 CFR 820/QMSR, 21 CFR 807, 803, 806; EU MDR (2017/745); ISO 13485 and ISO 14971. - Strong strategic mindset with ability to align regulatory strategy with engineering, quality, and business objectives. - Excellent communication skills, influencing capability, and experience working in global, matrixed environments. - Advanced regulatory writing and documentation oversight capability. - Demonstrated ability to mentor and develop a high-performing staff. - Ability to multi-task in a fast-paced environment. - Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills. Requirements - Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline (Advanced degree preferred). - Minimum 8–10+ years of progressive regulatory experience in the medical device field. - Demonstrated experience leading FDA Class I and II submissions (e.g., 510(k)) required. - Direct engagement with FDA required; experience interacting with EU Notified Bodies required. - RAC certification or equivalent preferred. Benefits - Health, Dental, and Vision insurance benefits - 401k plan with company match - Paid Time Off - Wellness initiative & Health Assistance Resources - Life Insurance - Short and Long Term Disability Benefits - Health and Dependent Care Flexible Spending Accounts - Commuter Benefits - Parental and Caregiver Leave - Tuition Reimbursement
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