At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

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 1.5°C 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.

We currently have an opening for a Manager, Regulatory Affairs. This position will support the Cardiac Assist business area and will be responsible for managing and directing the preparation, submission, tracking of official documents and files such as submission of 510(k) Notifications, Pre-market Approval Applications, Investigational Device Exemptions, Design Dossiers, Technical Files, Shonins and other applicable country regulatory submissions and requirements. Manages and develops regulatory department specialist staff.

Job Responsibilities

• Manages and develops regulatory staff personnel.
• Drives the compilation and publishing of regulatory submissions within specified deadlines.
• Ensures the quality of submissions generated. Provides expertise and consultation on proper preparation of submission documentation and files to relevant departments. Liaises with internal organizations to provide/solicit guidance and support for complex submissions.
• Manages project teams, driving timelines and deliverables related to submission documents.
• Interfaces with technical staff to facilitate and prioritize the development of domestic and/or global submissions.
• Prepares and manages department budget.
• Develops and implements cost controls as appropriate.
• Assures that a positive working relationship is developed and maintained between staff and internal/external customers.
• Develops and maintains high level relationships with key contacts in regulatory agencies.

Required Knowledge, Skills, and Abilities

• A Bachelor's degree in Engineering, Science or related field is required. A Master of Science in Engineering, Science or related field or MBA is preferred.
• A minimum of eight years of experience in regulatory affairs or related functions in an FDA regulated industry is required. Ten or more years of related experience is preferred.
• Experience must include work experience in mechanical engineering and working with devices with embedded software.
• Must have experience managing professional level employees.
• Must demonstrate strong organizational skills, effective written and verbal communication skills, including technical writing skills.
• Must have strong knowledge of regulatory submissions including 510k notifications and pre-market approval applications.

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About us

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise ‘Passion for Life’ close to heart.

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted MedTec company.

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.