Senior Regulatory Affairs Specialist
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Job Description
Senior Regulatory Affairs Specialist leading regulatory strategy, submissions, and compliance for Solventum’s healthcare devices. Supporting global approvals, audits, and product lifecycle requirements.
Responsibilities:
- Lead a regulatory affairs team primarily supporting the Restorative Healing Technologies portfolio
- Support early- and late-stage product development through critical milestones and regulatory activities leading to global product approvals
- Support ongoing product compliance throughout the device lifecycle
- Build strong relationships across stakeholders, management, and contract organizations
- Develop a team with the capacity and competence to support business strategic plans
- Develop and execute regulatory strategies for new product market authorizations, indications, and claims
- Manage complex regulatory decision-making among cross-functional stakeholders
- Represent Regulatory Affairs in global business and functional strategic meetings and forums
- Perform regulatory assessments and determine registration plans with the business
- Articulate global registration requirements and compile regulatory documents according to local requirements
- Submit registration documents and follow through on evaluations until regulatory authorization is obtained
- Act as the focal point for commercial support related to regulatory activities
- Manage regulatory systems and tools, data tracking, and regulatory data integrity
- Review advertising and promotional materials for alignment with cleared claims
- Monitor new regulations and provide regulatory information, updates, and documentation
- Support ISO 13485, MDSAP, and Technical Surveillance audits
- Complete additional duties, responsibilities, or assigned projects
Requirements:
- Bachelor’s Degree or higher (completed and verified prior to start) AND seven (7) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment OR High School Diploma/GED (completed and verified prior to start) AND eleven (11) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment
- Master’s Degree or higher in a scientific, engineering, regulatory, or quality discipline
- Three (3) years of experience preparing and/or supporting regulatory submissions, including 510(k) submissions, EU MDR submissions, or other international medical device regulatory submissions
- Three (3) years of experience supporting ISO 13485 and/or MDSAP audits
- Experience supporting regulatory activities for negative pressure wound therapy devices and/or wound care medical devices
- Experience supporting regulatory activities for absorbable wound care dressings and matrices
- Experience supporting regulatory activities for electro-mechanical devices and/or embedded or stand-alone software medical devices
- Must be legally authorized to work in country of employment without sponsorship for employment visa status
Benefits:
- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
- Up to 10% domestic/international travel opportunity
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