Senior Regulatory Affairs Specialist (Solventum)

Solventum Corporation; Eden Prairie (MN); On-site; USD 137,000 - 168,000; Full time

Job summary

An innovative healthcare company is seeking a Senior Regulatory Affairs Specialist to lead regulatory efforts following a corporate spin-off. This role is vital in shaping the global strategy to establish the new entity as a world-class healthcare provider. You will conduct regulatory assessments, support strategic initiatives, and ensure compliance for a range of medical products. Join a team dedicated to improving healthcare outcomes and making a significant impact in the industry. If you have a passion for regulatory affairs and want to contribute to groundbreaking solutions, this opportunity is perfect for you.

Qualifications

• Minimum 7 years of experience in regulatory affairs in drug and medical device industry.
• Direct experience authoring regulatory submissions/technical documentation.

Responsibilities

• Conduct global regulatory change assessments and coordinate activities for products.
• Lead regulatory filings for continuity projects in EU/USA and Canada.

Skills

Regulatory Acumen

Cross-Functional Project Management

International Submission Support

Education

Bachelor’s Degree in a Scientific Discipline

High School Diploma/GED

Job description

Senior Regulatory Affairs Specialist (Solventum)

Join to apply for the Senior Regulatory Affairs Specialist (Solventum) role at Solventum.

Base Pay Range

$137,439.00/yr - $167,981.00/yr

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. Please bear with us as we update our Careers Page and applicant documents. Our Privacy Policy continues to apply to any personal information you submit.

Job Description

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions, we pioneer innovations that change patients' lives for the better while enabling healthcare professionals to perform at their best.

The Impact You’ll Make in this Role

In this Senior Regulatory Affairs Specialist position, you will act as the lead Regulatory Affairs associate on enterprise-wide strategic cross-functional teams for continuity projects related to the 3M & Solventum spin-off for the Medical Surgical business. The role will significantly impact the global strategy to make Solventum a stand-alone world-class healthcare company.

As a Senior Regulatory Affairs Specialist, you will:

• Conduct global regulatory change assessments and coordinate associated activities for assigned products.
• Support global regulatory strategies for changes related to spin-off continuity projects.
• Demonstrate operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality.
• Provide regulatory review of technical reports and documents.
• Document and manage metrics.
• Lead regulatory filings as needed for continuity projects (directly for EU/USA, Canada and supporting ROW).
• Communicate results of technical tasks to teams and respective business groups.
• Lead the implementation of key corporate initiatives.

Your Skills And Expertise

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

• Bachelor’s Degree in a scientific discipline (e.g., Chemistry, Chemical Engineering) or higher AND
• Minimum seven (7) years of experience in regulatory affairs in the drug and medical device industry.

OR

• High School Diploma/GED AND fourteen (14) years of experience in regulatory affairs in the medical device industry.

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

• Direct experience authoring regulatory submissions/technical documentation.
• Experience working with regulatory support for wound dressings and/or surgical products.
• Skills include regulatory acumen, cross-functional project management, and international submission support.

Work location: Remote - United States
Travel: May include up to 10% [domestic/international]
Must be legally authorized to work in country of employment without sponsorship for employment visa status.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Solventum is an equal opportunity employer.

Please note: your application may not be considered if you do not provide your education and work history.