Senior Regulatory Affairs Specialist (m/f/*)

Senior Regulatory Affairs Specialist (m/f/*)

Apply remote type Hybrid locations DE, Neuss DE, Seefeld By time type Full time posted on Posted 4 Days Ago job requisition id R01119410

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals.

Job Description:

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients‘ lives for the better while enabling healthcare professionals to perform at their best.

The Impact You’ll Make in this Role

As a Senior Specialist Regulatory Affairs (m/f/*) , you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Acting as liaison between design center regulatory affairs, regulatory consultants and distributors to enable registrations in select EMEA countries
• Managing compliance projects, developing and implementing regulatory strategies and submissions for medical devices in select EMEA countries
• Ensuring compliance with country regulatory requirements for market access and vigilance of medical devices
• Implementing regulatory strategies during product development/ introduction and /or product modification, ensuring all changes reflected in country registrations including correct labelling
• Preparing and maintaining regulatory documents for registration submissions
• Communicating to authorities, notified bodies, consultants and distributors etc.
• Preparing country-specific documentation requests for registrations, bid & tenders & reimbursement
• Monitoring emerging regulations affecting medical devices in select EMEA countries.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education.
• Extensive experience in regulatory affairs in the medical device or pharmaceutical industry.
• Ideally, you have knowledge of the medical device regulations and standards including EN ISO 13485, EU MDR 2017/745, GMP, etc.
• Ability to work in cross-functional and cross-cultural teams
• Good communication and decision-making skills
• Ability to negotiate with regulatory agencies and notified bodies
• Ability to use databases and regulatory submission request tools
• Fluent English language skills, both written and verbal
• Additional EMEA languages are a plus

Work location:

• Hybrid in Düsseldorf or Seefeld or remote within Germany

Travel: May include up to 5% domestic & international

Must be legally authorized to work in country of employment without sponsorship for employment visa status.

Supporting Your Well-being

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Diversity & Inclusion

(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com . Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

Our Story

At Solventum, we create breakthrough solutions for our customers’ toughest challenges by pioneering game-changing innovations at the intersection of health, material and data science to change patients’ lives for the better — while enabling healthcare professionals to perform at their best.

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