Regulatory Affairs Specialist (/*) (New Health Care Company) in Seefeld bei 3M
Regulatory Affairs Specialist (m/f/*) (New Health Care Company) in Seefeld bei 3M
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”.
The impact you have in this role
As (Senior) Regulatory Affairs Specialist (m/f/*) for our Oral Care Division in Seefeld you will have the opportunity to put your curiosity to good use and collaborate with some of the most innovative and diverse people in the world. Here's how to make an impact:
- Obtain registrations for dental medical devices in EU and US, also in direct contact with authorities, as well as globally in cooperation with 3M Subsidiaries.
- Create and maintain registration documents and Technical Documentations.
- Represent Regulatory Affairs in new product development, product maintenance & other relevant projects.
- Review documents created by other functional areas for their suitability to ensure a successful global registration, and to provide consultation to other functional areas in regulatory-related questions.
- Optimize processes, create and maintain SOPs, support audits and inspections.
Your Skills and Expertise
To set you up for success in this role from day one, 3M is looking for candidates who must have the following qualifications:
- Science / engineering / pharmaceutical / medicinal studies (diploma, state examination or master’s degree).
- Expert working experience in Regulatory Affairs in medical device area, thereby in specific also practical experience with creating medical device dossiers for US, Canada and EU based on very good knowledge of current regulations.
- Fluent German and English language skills, also in writing.
Additional qualifications that could help you succeed even further in this role include
- Sound experience with developing global regulatory strategies in context with new product development (NPI) and product maintenance, and ideally also first experience in project management.
- First regulatory experience with other regions such as Asia-Pacific and Latin America.
- Used to work in a self-sufficient manner, having a good time management and enjoying challenging tasks, good analytical competency to assess complex context and able to present this assessment afterwards to other functional areas, e. g., business, in a comprehensible manner.
- Strong goal orientation, communication strength, team spirit as well as good computer skills.
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.
(*) 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 th