Job Description:
3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:
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Proven category leadership
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Exposure to attractive end-markets
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Innovation mindset driving improved patient outcomes
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Collaborative customer relationships
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Deep global regulatory experience
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Operational excellence and strong cash flow
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Strong sales growth and profitability with significant recurring sales
We expect the creation of the two companies will be completed by the end of 2023. For now, we will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company”.
This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.
The Impact You’ll Make in this Role
As a 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:
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Managing compliance projects, developing and implementing of regulatory strategies and submissions for medical devices and pharmaceuticals in select European countries , eg Germany, Switzerland .
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Ensuring compliance with current national and European regulatory and standard requirements for market access and vigilance of medical devices.
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Driving regulatory strategies during product development and modification.
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Creating, developing and maintaining of regulatory documents for European product submissions.
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Supporting and further developing of the quality management system according to EN ISO 13485, EU MDR 2017/745 and MDSAP.
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Communicating to regulatory authorities, notified bodies, consultants and distributors etc.
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Supervision of regulatory personnel .
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Act as Person Responsible for Regulatory Compliance / Deputy according to EU MDR
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Ensure obligations of Swiss Authorized Representative and EU Authorized Representative according to EU and Swiss Medical Device Law are executed
Your Skills and Expertise
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
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Engineering/scientific university degree (Master, Bachelor) or a comparable qualified education.
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Experience in regulatory affairs and with quality management systems in the medical device or pharmaceutical industry.
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Good English language skills, both written and verbal
Additional qualifications that could help you succeed even further in this role include:
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You have knowledge of European medical device regulations and quality management systems eg EN ISO 13485, EU MDR 2017/745, MDSAP, GMP, etc.
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Ability to work in cross-functional and cross-cultural teams
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Good communication and decision-making skills
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Ability to negotiate with regulatory agencies and notified bodies
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Ability to use databases and regulatory submission request tools
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Experience in working with distributors and consultants
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.
Chat with Max
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(*) At 3M, diversity & inclusion are essential to innovation. We seek and value differences in people! This Job ad is addressed to all potential candidates. As an equal opportunity employer 3M will not discriminate against any applicant for employment on the basis of religion, sex, sexual orientation, gender identity, national origin, age or disability.
Our approach to flexibility is called Work Yo