Manager Regulatory Affairs - Cardiac Surgery/ACT

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Summary:

The Manager of Regulatory Affairs is responsible for leading the preparation, submission, and tracking of regulatory filings, including but not limited to 510(k) notifications, PMAs (Pre-Market Approval Applications), IDEs (Investigational Device Exemptions), Design Dossiers, and Technical Documentation Files. This role ensures compliance with global regulatory requirements and supports the Acute Care Therapy (ACT) business area, particularly the Cardiac Surgery division, as well as other business segments as needed.

This position is a fixed term position for one year and fully remote.

Key Responsibilities:

• Lead the planning, compilation, review, and submission of high-quality regulatory filings in a timely manner to global health authorities.
• Ensure the accuracy, consistency, and completeness of all documentation prepared for submission.
• Provide strategic regulatory guidance to cross-functional teams, including R&D, Quality, and Marketing, to support product development and lifecycle management.
• Collaborate with technical teams to identify regulatory pathways and ensure the prioritization of submission-related deliverables.
• Manage and lead project teams focused on regulatory deliverables, ensuring alignment with business timelines and objectives.
• Build and maintain effective relationships with global regulatory agencies, serving as the primary point of contact for submission-related inquiries and communications.
• Monitor and interpret relevant regulatory requirements and industry trends to ensure ongoing compliance and proactive risk management.
• Develop and implement budget-conscious processes and controls for regulatory activities.
• Foster positive collaboration across internal teams and external stakeholders to ensure seamless regulatory operations.

Knowledge Skills and Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required.
• Advanced degree (M.S., M.B.A., or related field) preferred.
• A minimum of 12 years of progressive experience in regulatory affairs within an FDA-regulated industry
• Proven expertise in preparing and submitting U.S. and international regulatory filings, including 510(k)s and PMAs.
• Solid knowledge of medical device regulations and global regulatory requirements (e.g., FDA, EU MDR, Health Canada, Japan PMDA).
• Strong project management, organizational, and time-management skills.
• Exceptional communication skills-both verbal and written-with the ability to effectively present complex information to internal and external stakeholders.
• Demonstrated ability to lead cross-functional teams in a matrixed environment

The base salary for this position is a minimum of $140,000 and a maximum of $165,000.

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.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.