Regulatory Director
Montante Solar
Senior Regulatory Affairs Manager
Revvity
full-time
Posted on:
Location Type: Remote
Location: Remote • Florida, Massachusetts, New Jersey, North Carolina, Virginia • 🇺🇸 United States
Visit company websiteSalary
💰 $140,000 - $150,000 per year
Job Level
Senior
About the role
- Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs
- Ensure participation on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements
- Develop North America regulatory strategies plan for submission for IVD products
- Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment
- Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products
- Maintain up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business
- Provide input and feedback on clinical study protocols to ensure regulatory requirements are incorporated
- Support CE marking activities for IVD products and other market clearance for products manufactured globally
- Review and approve promotional materials and product labeling
- Support importation/exportation permitting activities
Requirements
- Bachelor's Degree in a STEM field
- 6+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions) OR Master's or PhD degree in a STEM field
- 4+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions)
- Travel as circumstances dictate
- Excellent understanding of regulations and guidance documents required in Americas region
- RAC certified
- Excellent interpersonal, verbal and written communication skills (in English)
- Excellent time management, organizational, negotiation, and problem-solving skills
- Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management.
Benefits
- Medical, Dental, and Vision Insurance Options
- Life and Disability Insurance
- Paid Time-Off
- Parental Benefits
- Compassionate Care Leave
- 401k with Company Match
- Employee Stock Purchase Plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsIVD productsclinical study protocolsUS 510(k)PMADE NoVo submissionsregulatory strategiesimpact assessmentCE markingpromotional materials review
Soft skills
interpersonal skillsverbal communicationwritten communicationtime managementorganizational skillsnegotiation skillsproblem-solving skillsindependent workrelationship buildingmatrixed organizational structure
Certifications
RAC certified
