Sr. Regulatory Affairs Specialist, CS

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 Sr. Regulatory Affairs Specialist supporting the Cardiac Surgery product area. This position is responsible for activities which lead to and maintain regulatory approval to market medical devices i.e. preparation, submission, tracking of official documents and files.  Additionally, it is responsible for assessment of device and labeling changes for regulatory implications.

Key duties and responsibilities:

•Develop and maintain positive relationships with U.S. FDA, EU Notified Body and global regulatory agencies through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.

•Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies or compliance issues.

•Develop and implement strategies for regulatory approval of medical devices.

•Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams and marketing/sales.

•Coordinate submission activities for a variety of device regulatory approvals including: US premarket submissions (IDE, 510(k) etc.), international submissions, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.

•Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes.

•Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes.

•Participate in department/systems development initiatives.

•This is not an inclusive list of job responsibilities

Knowledge/Skills/Experience:

•A Bachelor’s degree in a scientific or technical discipline is required or equivalent work experience. Advanced degree preferred.

•A minimum of five years Medical Device Regulatory Affairs experience is required.

•Must have working knowledge of FDA and international regulations/standards.

•Must have general understanding of product development process and design control.

•Must be able to manage several projects simultaneously.

•Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications is preferred.

•Must demonstrate effective research and analytical skills.

•Must demonstrate effective written and verbal communication, including technical writing skills.

•Must be able to work independently with minimal supervision.

Salary range: $105K - $120k

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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. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. 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 Medtech company.

Benefits at Getinge:

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

• Health, Dental, Vision and Travel insurance benefits
• Registered Pension Plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Hybrid Work Arrangements (where applicable)
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Accommodations are available upon request for candidates taking part in all aspects of the selection process.