Specialist Regulatory Affairs (m/f/*) (New Health Care Company)

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:    Proven category leadership Exposure to attractive end-markets Innovation mindset driving improved patient outcomes Collaborative customer relationships Deep global regulatory experience Operational excellence and strong cash flow 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: Managing compliance projects, developing and implementing of regulatory strategies and submissions for medical devices and pharmaceuticals in select European countries , eg Germany, Switzerland . Ensuring compliance with current national and European regulatory and standard requirements for market access and vigilance of medical devices. Driving regulatory strategies during product development and modification. Creating, developing and maintaining of regulatory documents for European product submissions. Supporting and further developing of the quality management system according to EN ISO 13485, EU MDR 2017/745 and MDSAP. Communicating to regulatory authorities, notified bodies, consultants and distributors etc. Supervision of regulatory personnel . Act as Person Responsible for Regulatory Compliance / Deputy according to EU MDR 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: Engineering/scientific university degree (Master, Bachelor) or a comparable qualified education. Experience in regulatory affairs and with quality management systems in the medical device or pharmaceutical industry. Good English language skills, both written and verbal Additional qualifications that could help you succeed even further in this role include: You have knowledge of European medical device regulations and quality management systems eg EN ISO 13485, EU MDR 2017/745, MDSAP, 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 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 For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers. (*) 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 Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals. Our global Work Your Way initiative gives our employees flexibility in where and how their work can be performed, subject at all times to any location-specific rules and policies that may be in place from time to time (more information on such rules/policies can be provided upon request from the relevant in-location HR). 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. 3M Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at 3M are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms. 3M is establishing two industry -leading companies, creating value through the spin-off of its Health Care business. To search job opportunities in 3M Health Care, click here. For more information on the 3M Health Care spin off, click here: Health Care | 3M US At 3M we apply science in collaborative ways to improve lives daily as our employees connect with customers all around the world. Learn more about 3M's creative solutions to global challenges at www.3M.com or on Twitter @3M or @3MNews.