Senior Regulatory Affairs Specialist

vor 3 Monaten

Neuss, Deutschland Solventum Vollzeit

Job Description:
3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role
As a Senior Regulatory Affairs Specialist (M/F/*) in Düsseldorf, 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 international regulatory strategies for medical devices._- Ensuring compliance with current national, European and international regulatory and standard requirements for manufacturing, market access and vigilance of medical devices._- Driving regulatory strategies during product development or product modification._- Creating, developing and maintaining of regulatory documents for European and international product submissions._- Supporting and further developing of the quality management system according to EN ISO 13485, EU MDR 2017/745 and MDSAP._- Communicating to authorities, notified bodies, etc._

Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
- Engineering/scientific_ university degree (Dipl., Master, Bachelor) or a comparable qualified education._- Experience in regulatory affairs and with quality management systems in the medical device or pharmaceutical industry._- Ideally, you have knowledge of the medical device regulations EN ISO 13485, EU MDR 2017/745, MDSAP, US QSR, GMP, etc._- Fluent German and English language skills, both written and verbal_

Additional qualifications that could help you succeed even further in this role include:
- Ability to work in cross-functional and cross-cultural teams_- Good communication and decision-making skills_

Work location:

- Hybrid Eligible (Job Duties allow for some remote work but require travel to Düsseldorf at least 1 day per week)

Supporting Your Well-being

Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Diversity & Inclusion

(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, _sexual orientation_, age, civil status, disability, family status, or membership of the travelling community.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Solventum Global Terms of Use and Privacy Statement

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