Regulatory Affairs Manager* (New Health Care Company)

Description

Job Description: Regulatory Affairs Manager* (New Health Care Company) 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 Regulatory Affairs Manager, 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:

• Developing and executing regulatory strategies to achieve products approvals faster than competitors and with differentiated indications and claims.
• Directing complex decision making among stakeholders and senior leaders in an area of regulatory that is complex and evolving.
• Advising and guiding the regulatory strategy development, Health Authority interactions, and submission activities.
• Participate in global business and functional strategic leadership meetings and forums representing regulatory affairs perspective.
• Mentoring and guiding regulatory staff and teams working across all product modalities.
• Establishing organization goals and objectives.
• Partnering with health economics, reimbursement, and government affairs to influence regulations globally to provide the best product position/price for our patients.
• Supporting new venture initiatives and acquisitions/ integrations.

Your Skills and Expertise To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

• Bachelor’s Degree or higher in a scientific discipline (completed and verified prior to start) from an accredited university and a minimum of seven (7) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment

OR

• High School Diploma/GED (completed and verified prior to start) from an accredited institution and a minimum of fourteen (14) years of experience in Regulatory Affairs & Medical Device experience

Additional qualifications that could help you succeed even further in this role include:

• Experience with 510(k) applications, EU MDR submissions, and other international medical device regulations and submissions.
• Previous experience and demonstrated success leading a team and managing direct reports
• Excellent verbal and written communication skills

Work location:

• Hybrid Eligible (Job Duties allow for some remote work but require travel to 3M Center in Maplewood, MN at least 1 day per quarter)

Travel: May include up to 10% domestic/international Relocation Assistance: Not authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Responsibilities of this position may include direct and/or indirect physical or logical access to information, systems, technologies subjected to the regulations/compliance with U.S. Export Control Laws. U.S. Export Control laws and U.S. Government Department of Defense contracts and sub-contracts impose certain restrictions on companies and their ability to share export-controlled and other technology and services with certain "non-U.S. persons" (persons who are not U.S. citizens or nationals, lawful permanent residents of the U.S., refugees, "Temporary Residents" (granted Amnesty or Special Agricultural Worker provisions), or persons granted asylum (but excluding persons in nonimmigrant status such as H-1B, L-1, F-1, etc.) or non-U.S. citizens. To comply with these laws, and in conjunction with the review of candidates for those positions within 3M that may present access to export controlled technical data, 3M must assess employees' U.S. person status, as well as citizenship(s). The questions asked in this application are intended to assess this and will be used for evaluation purposes only. Failure to provide the necessary information in this regard will result in our inability to consider you further for this particular position. The decision whether or not to file or pursue an export license application is at 3M Company's sole election. 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. The expected compensation range for this position is $155,615 - $190,196, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.3m.com/3M/en_US/careers-us/working-at-3m/benefits/. Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M. Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. 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. You have flexibility in where and when work gets done. It all depends on where and when you can do your best work. Pay & Benefits Overview: https://www.3m.com/3M/en_US/careers-us/working-at-3m/benefits/ 3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. 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
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