Senior Regulatory Affairs Specialist – Solventum
| Company | Solventum |
|---|---|
| Location | Remote in USA, Minnesota, USA |
| Salary | $137439 – $167981 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s Degree in scientific discipline (e.g. Chemistry, Chemical Engineering) or higher AND Minimum seven (7) years of experience in regulatory affairs in the drug (pharmaceutical) and medical device industry including experience working on combination medical devices.
- High School Diploma/GED from AND (14) fourteen years of experience in regulatory affairs in the medical device industry
Responsibilities
- Conducting global regulatory change assessments and coordinating associated activities for assigned products.
- Supporting global regulatory strategies for changes related to spin-off continuity projects and ensuring these strategies are integrated with the overall RA spin-off plans.
- Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality
- Demonstrating 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, Canada 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, 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.
Preferred Qualifications
- Direct experience authoring regulatory submissions/technical documentation
- Direct experience authoring regulatory strategies and regulatory change assessments
- Experience working with regulatory support for wound dressings and/or surgical products
- Experience working and providing regulatory support for new product development teams
- Experience developing regulatory strategies, label and claims review and 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