Job Description
Note: The job is a remote job and is open to candidates in USA. Solventum is a new healthcare company focused on improving lives through innovative solutions. The Senior Regulatory Affairs Specialist will lead regulatory strategies and assessments to optimize the business's supply chain, ensuring compliance and efficiency in regulatory processes.
- Responsibilities
- Supporting global regulatory strategies for changes related to on an enterprise-wide strategic initiative to optimize the business’s supply chain and ensuring these strategies are integrated with the overall RA plans
- 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
- 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 (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
- Skills
- Bachelor's Degree or higher in a science or engineering discipline (completed and verified prior to start) AND five (5) years of experience in regulatory affairs in the medical device industry in a private, public, government or military environment
- OR
- High School Diploma/GED AND nine (9) years of experience in regulatory affairs in the medical device industry in a private, public, government or military environment
- Experience working on combination medical devices with an antimicrobial
- Direct experience authoring regulatory submissions/technical documentation
- Direct experience authoring regulatory strategies and regulatory change assessments
- Experience working and providing regulatory support for new product development teams
- Experience developing regulatory strategies 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
- Benefits
- Medical
- Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
- Company Overview
- At Solventum, we enable better, smarter, safer healthcare to improve lives. We never stop solving for you. It was founded in undefined, and is headquartered in , with a workforce of 10001+ employees. Its website is https://www.solventum.com/.
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