[Hiring] 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, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. This role ensures consistent compliance with U.S. (FDA), EU MDR (2017/745), and applicable global regulations, enabling innovation and growth while maintaining regulatory integrity throughout the product lifecycle.

This leader collaborates with product development, quality, operations, marketing, clinical affairs, and global regulatory teams to integrate regulatory risk management early and continuously in the product lifecycle. The role serves as a primary point of regulatory accountability for cross-functional leadership engagement and health authority interactions across FDA, EU Notified Bodies, and ROW competent authorities, while partnering with regional regulatory teams to support international market requirements.

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.
• Must possess detail-oriented knowledge of FDA regulations including Quality System Regulations (QSR), submissions, complaint handling, Field Actions (Customer Notifications/Corrections/Removals) and ISO 13485, MDD/EUMDR, and other equivalent requirements.
• 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.
• Must have demonstrated ability to mentor and develop a high-performing staff.
• Demonstrated ability to select, organize, lead, participate, and facilitate a team to produce results.
• Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment.
• Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills.
• Demonstrated proficiency in regulatory planning and strategy submissions along with strong negotiation skills.
• Ability to represent Regulatory Affairs to other departments.

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; demonstrated experience with EU MDR (2017/745) Technical Documentation and conformity assessment required; working knowledge of other global (ROW) regulatory frameworks required.
• Direct engagement with FDA required; experience interacting with EU Notified Bodies required; experience with ROW competent authority interactions preferred.
• 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