Senior Manager, Regulatory Affairs

Job title: Senior Manager, Regulatory Affairs

About the Role Lead regulatory strategy and execution for U.S., EU MDR, and ROW to enable timely, compliant market access for Getinge’s SWICC portfolio and related equipment. Ensure ongoing regulatory compliance and lifecycle governance from concept through post-market, collaborating with cross-functional teams and engaging health authorities as needed.

What You'll Do

• Develop and execute global device classifications and regulatory strategies for SWICC products, aligning requirements with business objectives and roadmaps.
• Drive U.S. submissions (510(k), De Novo when applicable) and global filings, ensuring structured, defensible regulatory pathways for FDA Class I & II and EU MDR Class I, IIa, and IIb devices.
• Integrate regulatory requirements early in concept and design phases to prevent rework and accelerate time to market.
• Continuously identify and communicate regulatory risks and emerging requirements to senior leadership and develop mitigation plans.
• Monitor global regulatory developments, trends, and best practices to inform strategy and business readiness.
• Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning.
• Assess regulatory impact of product and manufacturing changes, providing strategic guidance on change control and compliance options.
• Review and approve product claims, labeling, instructions for use, and commercial materials for regulatory consistency and claims support.
• Oversee development, quality control, and submission readiness for dossiers targeting the U.S., EU, and other international markets; serve as primary interface with regulatory authorities.
• Provide regulatory leadership for post-market obligations (MDR reporting, corrections/removals), inspections, and audits; support EU Notified Body and ROW inspections.
• Mentor and develop regulatory team members; promote best practices and continuous improvement across the SWICC portfolio.

What We're Looking For

• 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 understanding of FDA regulations including QSR, submissions, complaint handling, Field Actions (Corrections/Removals), and ISO 13485, MDD/EUMDR.
• Strong strategic mindset with the ability to align regulatory strategy with engineering, quality, and business objectives.
• Excellent communication and interpersonal skills with the ability to influence across global teams.

Nice to Have

Compensation & Benefits

• Salary range: USD 161,920.00 - 202,400.00 annually plus a target bonus of 25%
• Remote work: 5 days at home (fully remote)
• Other benefits not specified in the posting