Senior Manager, Regulatory Affairs
Job Overview
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.
Job Responsibilities and Essential Duties
Lead development and execution of comprehensive global device classifications and regulatory strategies for SWICC products, aligning regulatory requirements with business objectives and product roadmaps
Drive U.S. submissions (e.g., 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, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making
Assess regulatory impact of product and manufacturing changes (design, suppliers, processes, labeling), providing strategic guidance on change control and compliance options, ensuring U.S. regulatory compliance while aligning with international regulatory colleagues on global impact
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 markets and other international technical documentation as required
Serve as primary interface with regulatory authorities (e.g., FDA, and Notified Bodies and other competent authorities in collaboration with regional regulatory teams) including pre-submission interactions, submission responses, deficiency management, and post-submission negotiations
Ensure regulatory documentation and systems (e.g., technical files, regulatory records) meet compliance requirements and audit expectations
Provide regulatory leadership for compliance and reporting obligations including U.S. corrections & removals, MDR reporting, and support EU FSCA/competent authority interactions and other global vigilance reporting activities in coordination with regional regulatory teams
Support inspections and audits with effective regulatory representation, ensuring rapid closure of findings and continued compliance readiness, with primary responsibility for U.S. FDA inspections and direct support for EU Notified Body audits and ROW competent authority inspections
Mentor and develop regulatory team members, fostering regulatory judgement, strategic thinking, and subject-matter expertise
Advocate for and integrate regulatory best practices and continuous improvement of regulatory processes, templates, and tools across the SWICC products portfolio
Influence stakeholders across global teams through clear regulatory rationale and practical implementation guidance
About Us
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.
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
Equal Opportunity Employer
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.