Senior Regulatory Affairs Specialist

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
In this Senior Regulatory Affairs position, you will have the opportunity to act as the lead for regulatory affairs on cross functional teams and have ownership of product line submissions and registrations across the globe, for the dental solutions business. The role will have a significant impact for Tier 1 country registrations in high volume markets (US, Canada, EU, etc.). The position will work with the international regulatory affairs group to ensure products are registered globally based on the business strategy. In addition, you will have the opportunity to support labeling and registration changes to due the company spin-off.

As a Senior Regulatory Affairs Specialist (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:

- Conducting global regulatory change assessments and coordinating associated activities for assigned products.

- 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 of technical reports and documents.

- Providing contributions for development and implementation of regulatory processes.

- Documenting and managing metrics.

- Leading regulatory filings as needed for continuity projects (directly for EU/USA, and supporting ROW).

- Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight.

- Communicating results of technical tasks to teams supported, respective business group(s) and/or country/region served via reports, standards and/or presentations.

- Leading the implementation of key corporate initiatives and appropriate tools.

The job also requires performing other duties as assigned. Percentages of time spent on job duties are estimates and may vary for each position.

A successful candidate for this role:

- Possesses thorough understanding of concepts and professional practices to solve complex and diverse regulatory problems.

- Has exceptional attention to detail, written and oral communication skills.

- Applies methodology of process improvement when applicable.

- Utilizes strong technical and non-technical communication skills of listening, reading, writing, and speaking and continuously improves upon these skills through regular participation in appropriate training activities.

- Maintains broad knowledge of assigned organization's products, broad industry trends, and customer needs.

- Capable of developing understanding of technologies and/or products across multiple divisions.

- Possesses knowledge of and regularly utilizes available information resources and systems.

- Collaborates with colleagues to innovate, influence, and/or negotiate when required.

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 scientific discipline such as Biology, Chemistry, Biomedical Engineering or Physics.

- 7-10 years in regulatory affairs in the medical device industry

- Direct experience authoring submissions/technical documentation for US, Canada, EU and supporting EMEA, APAC and LATAM regions

- Direct experience authoring regulatory strategies and regulatory change assessments

- Direct experience revising, reviewing and approving labeling (including marketing claims) that meet global regulatory requirements

- Must have experience and expertise in design control verification and validation activities, as well as expertise in clinical requirements for medical devices; in particular, experience with assisting teams with documenting and performing to applicable requirements, and assisting with writing, reviewing and approving all protocols and reports

- Expert technical writing and verbal skills in the English language

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

- Experience in project management

- Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software

Work location: Hybrid Eligible (Job Duties allow for some remote work but require travel to Wrocław at least 1 day per week)

Travel: May include up to 10% 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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