Associate Director, Regulatory Affairs (m/f/x)*

Solventum; Seefeld; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Join Solventum as an Associate Director in Regulatory Affairs, leading a team and managing the development of regulatory submissions for innovative dental solutions. This role requires a Bachelor’s degree, substantial experience in regulatory affairs, and proven leadership skills. The position, based in Seefeld, offers a chance to contribute to impactful healthcare solutions while ensuring compliance and operational excellence. With a focus on quality and speed, you will work closely with teams across geographies to drive regulatory strategies, making a difference in the medical device industry.

Qualifikationen

• Profound experience in regulatory affairs in the medical device industry.
• Direct experience authoring submissions/technical documentation.
• Direct experience managing a team of 5 or more.
• Fluent in English communication (verbal and written).
• Exceptional attention to detail and strong communication skills.

Aufgaben

• Leading and developing a team of individuals at the Seefeld plant for the Dental Solutions Business.
• Providing expertise in developing EU MDR compliant technical documentation.
• Supporting submissions and strategies in US, Canada, and ROW.
• Providing regulatory review and oversight of submission documentation.
• Oversight of post market renewals and operations using a RIMS platform.

Kenntnisse

Regulatory acumen

Team management

Stakeholder management

Medical Devices

Office Suite

Regulatory Management Software

Ausbildung

Bachelor’s Degree or higher in a physical, chemical, biological, statistical, or engineering science

Jobbeschreibung

Associate Director, Regulatory Affairs (m/f/x)*

Join to apply for the Associate Director, Regulatory Affairs (m/f/x)* role at Solventum

Associate Director, Regulatory Affairs (m/f/x)*

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Join to apply for the Associate Director, Regulatory Affairs (m/f/x)* role at Solventum

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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 An Associate Director, Regulatory Affairs (m/f/x)*, 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

• Leading and developing a team of individuals located at our Seefeld Germany plant, for the Dental Solutions Business
• Providing expertise in developing EU MDR compliant technical documentation, including expertise in technical writing
• Support team in US, Canada and ROW submissions and strategies
• Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills
• Providing regulatory review and oversight of submission documentation including deficiency responses and communications with notified bodies and other health authorities as applicable
• Oversight of post market renewals and operations through the use of a RIMS platform; seeks opportunities for innovative approaches to meeting regulatory requirements through the use of AI
• Establishes working relationships and interfaces and with multiple government and non-government organizations having an impact on market access and distribution.
  
  

Your Skills And Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s Degree or higher from an accredited university in a physical, chemical, biological, statistical, or engineering science or equivalent
• Profound experience in regulatory affairs in the medical device industry
• Direct experience authoring submissions/technical documentation
• Direct experience managing a team of 5 or more
• Fluent in English communication (verbal and written)
• Exceptional attention to detail as well as strong technical and non-technical communication skills
  
  

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

• Experience working in the dental device field or with dental products
• Experience working with formulated products
• Fluent in German language
• Experience developing regulatory strategies, label and claims processes and project management
• Skills include regulatory acumen, team management and development, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software
  
  

Work location: Remote

Travel: May include up to 25% domestic/international

Must be legally authorized to work in country of employment without sponsorship for employment visa status.

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.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

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.

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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

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Medical Equipment Manufacturing

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