Regulatory Specialist
What's the Job?
Lead and execute international addendum labeling requests, including Instructions for Use (IFUs), import labeling, and supplemental labeling.
Manage project plans, timelines, and stakeholder communications to ensure timely and compliant implementation of labeling changes.
Assess regulatory and quality system requirements to develop compliant labeling strategies for complex product portfolios.
Collaborate with cross-functional teams across Regulatory Affairs, Quality, Supply Chain, and Manufacturing to drive alignment and resolve issues.
Monitor emerging regulations and translate regulatory requirements into operational processes to ensure ongoing compliance.
What's Needed?
- Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or related field.
- Minimum of 6 years of experience in Regulatory Affairs, Regulatory Operations, Quality, or Compliance within a regulated industry.
- Significant experience with medical devices, pharmaceuticals, or biotechnology products.
- Proven ability to develop regulatory labeling strategies and lead complex post-approval initiatives.
- Strong project management skills, including managing timelines, risks, and stakeholder expectations.
About the Role
The ideal candidate will have strong regulatory knowledge, excellent project management skills, and the ability to collaborate effectively across diverse teams and geographies, which will align successfully in the organization.
Requirements
None specified.
Qualifications
None specified.
Skills
None specified.
Benefits
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account
- Health Flexible Spending Account
- Dependent Care Flexible Spending Account
- Supplemental Life Insurance
- Short Term and Long Term Disability Insurance
- Business Travel Insurance
Pay
Weekly Pay
Schedule
N/A