Compliance Analyst II
CareSource
Senior Regulatory Affairs Specialist
Solventum
full-time
Posted on:
Location Type: Remote
Location: Remote • Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $137,439 - $167,981 per year
Job Level
Senior
About the role
- 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.
Requirements
- 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, 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
Benefits
- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory change assessmentsregulatory strategiesregulatory submissionstechnical documentationproject managementlabel and claims reviewregulatory acumeninternational submission supportmedical devices
Soft skills
organizational skillsprioritizationoral communicationwritten communicationresults-orientedagilityquality focusstakeholder managementcross functional project management
Certifications
Bachelor’s DegreeHigh School Diploma/GED
