Leader Regulatory Affairs Emea

vor 21 Stunden

Neuss, Deutschland 3M Vollzeit

Job Description:
Collaborate with Innovative 3Mers Around the World

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 96,000 other curious, creative 3Mers.

“For more than 30 years at 3M, I’ve seen firsthand how it’s a place where curious, creative and collaborative people thrive and build a rewarding career. As a leader in this company, my goal is to ensure each 3Mer sees and feels the positive impact we’re making around the world” - Mike Roman, chief executive officer and chairman of the board at 3M

The Impact You’ll Make in this Role

As a Regulatory Affairs Associate, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Primary Responsibilities include but are not limited to the following:

- Lead/coordinate regulatory strategy for EMEA including resources and regulatory approaches
- Provide support and expertise as part of the Regulatory organization using knowledge of EMEA regulatory requirements and paths to support achievement of business objectives.
- Prepare Technical Documentation for Consumer Health products
- Assure that all device listings, import licenses, establishment licenses, and registrations for Consumer Health products are accurate and up to date
- Advise on new regulatory strategies
- Review product labeling and claims for compliance to applicable regulations
- Represent Regulatory Affairs on multidisciplinary project teams including New Product Introductions and Change Management Projects
- Provide local QMS or Distribution Quality assistance as required
- Participate and provide support to EMEA Regulatory
- Ensure compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance / vigilance

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 Pharmacy/Pharmacist or other technically relevant degree
- Experience in Regulatory Affairs or other technical function

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

- Regulatory Affairs experience in EMEA
- EU MDR knowledge and experience
- Ability to interface with regulatory agencies
- Good English speaking skillsets
- Proficient in Microsoft Office Tools

Travel: May include up to 5% domestic / international

Work location: Hybrid or Remote eligible

Supporting Your Well-being

Fair, performance-oriented and competitive payment is fundamental for 3M. To be attractive to the best talents, we regularly monitor the standards in the market. In addition, depending on the position and location, a wide range of social benefits is offered - including, for instance, additional payments such as vacation pay, a company pension and benefits under collective agreements and non-tariff agreements. A good work-life balance is the best basis for motivated employees, therefore flexibility has been part of our DNA since the beginning. We want your job suits best to your life situation - not the other way around Depending on the position and possibilities, we offer individual, flexible work models.

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