Manager Regulatory Affairs (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.

Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5C above pre-industrial levels.

We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

Job Overview:

The Manager, Regulatory Affairs will lead cross-business Regulatory programs for our Acute Care Therapies (ACT) medical device businesses (Cardiovascular Surgery, Cardiac Assist, Endovascular Solutions, Cardiopulmonary, Critical Care, Digital Solutions, and Transplant Care). The scope of the Regulatory Program Management responsibilities may change over time based on business needs and priorities but with a consistent purpose of driving simple, harmonized, compliant, and sustainable solutions for all Regulatory teams. The initial focus of the position will be to lead the ACT global EU MDR implementation program and electronic IFU (eIFU) solution.

This position may be based at any Getinge location, with a preference for Wayne (New Jersey). Remote locations are considered if on Eastern Standard Time (EST) zone, in order to virtually support a majority of the Getinge business locations.

Job Responsibilities and Essential Duties

• ACT Regulatory Program leader for Regulatory projects that impact more than one business within the Getinge Acute Care Therapy businesses with the purpose of driving harmonization and consistency in solutions and leveraging best practices.
• EU MDR implementation program leader with responsibility for collaborating with Business Unit Regulatory Affairs team members (and their supply chain and manufacturing counterparts) and Country Regulatory Affairs team members to ensure timely global implementation of EU MDR compliant products. Responsibility for global tracking and reporting of progress and issue escalation and resolution.
• Regulatory leader for the implementation and ongoing compliance and maintenance of an electronic IFU (eIFU) portal for Getinge's medical device companies.
• Develop regulatory subject matter expertise on EU MDR and global medical device labelling for the product areas within Getinge's Acute Care Therapies businesses.
• Create and maintain master worldwide labelling guidance on behalf of Getinge's medical device companies, including identifying labelling requirements for various levels of packaging, instructions for use, electronic IFUs, language requirements, and direct part marking.
• Partner with Getinge regulatory teams on new product development projects and changes to existing products to provide input and guidance with respect to labelling requirements.
• Partner with Getinge country Regulatory teams to ensure country-specific labelling requirements are communicated to, and implemented within, the Getinge medical device businesses.
• Monitor the external landscape to stay aware of changes in labelling regulations, particularly as it relates to electronic labelling, and proactively communicate new requirements to internal stakeholders.
• Participation in internal and third-party audits, providing support to the business area regulatory teams related to Programs within scope of responsibility, for example EU MDR implementation and labelling.
• Potential to participate in industry groups and standard development groups related to labelling topics.

Required Knowledge, Skills and Abilities

• Bachelor's Degree is required. Advanced degree is preferred.
• Minimum of 6 years medical device regulatory affairs experience is required.
• Experience with EU MDR and international product registration requirements is required.
• Prior experience with medical device labelling requirements is required.
• Prior experience leading a complex project or program is required.
• Strong communication and collaboration skills is required, including ability to build business relationships virtually.
• Prior experience with eIFU solutions is preferred.
• Prior experience with both capital equipment, software, implantable, disposable, and reusable medical products is preferred.
• Expertise in developing and executing successful regulatory strategies and submissions for U.S. and EU medical devices is preferred.
• Experience with external standards organizations or policy groups is preferred.

The base salary for the position is a minimum of $ 140,000 and a maximum of $ 175,000, plus annual bonus of 15%

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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 at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 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

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.