Overview
Associate Director, Regulatory Affairs (m/f/x)*
Thank you for your interest in working for our Company. Solventum was formed on April 1, 2024 after a corporate spin-off from 3M Healthcare. We are updating our Careers Page and applicant documents, which currently have 3M branding. The 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 with 3M, all qualified applicants will receive consideration for employment without regard to 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. We are a new company with a long legacy of creating breakthrough solutions for our customers. We pioneer game-changing innovations at the intersection of health, material and data science that improve patients’ lives and help healthcare professionals perform at their best. We partner closely with the brightest minds in healthcare to ensure every solution we create merges the latest technology with compassion and empathy.
The Impact You’ll Make in this Role
* Leading and developing a team 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.
* Supporting submissions and strategies in the US, Canada and Rest of World (ROW).
* Demonstrating an operational and strategic mindset that is results-oriented with speed, agility, and quality, and strong 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.
* Overseeing post-market renewals and operations through the use of a Regulatory Information Management System (RIMS); seeking opportunities for innovative approaches to meeting regulatory requirements through AI.
* Establishing working relationships 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
* 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 and Travel
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.
Additional Information
Supporting Your Well-being: Solventum offers programs to help you live your best life physically and financially. We benchmark pay and benefits with comparable companies.
Diversity & Inclusion: We are an equal opportunity employer and value diversity. We do not discriminate on 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 will be from an @solventum.com domain. Be wary of unsolicited emails or messages from other domains.
Please note: your application may not be considered if you do not provide your education and work history, either by uploading a resume or entering the information into the application fields directly.
Solventum Global Terms of Use and Privacy Statement: Carefully read these Terms of Use before using this website. Your access to and use of this website and application are conditioned on your acceptance and compliance with these terms. 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 terms.
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