Sr. Regulatory Specialist
Evergen
Summary
Education: Bachelor's degree
Job description
Responsibilities
- Leads regulatory support to product development teams, including preparation of regulatory opinion documents, coordination of labeling activities and review and approval of design control documentation, risk management reports, technical protocols and reports, and other outputs of product development
- Develops, reviews, and approves labeling, advertising, and promotional material to ensure consistency with approved claims and regulatory requirements
- Maintains awareness of global regulatory and product changes and leads impact assessment of changes
- Ensures assigned metrics are maintained, including preparing, tracking and trending reports, supporting audits, and providing timely feedback to stakeholders
- Develops and maintains effective working relationships with internal and external stakeholders to support needs of the business
- Supports company and departmental quality and business objectives and initiatives
- Reports on assigned project metrics and provides timely feedback to stakeholders
- Other duties as assigned
Requirements
Education: Bachelor's degree
Experience: 6+ years of experience as a regulatory specialist in a relevant medical device or pharmaceutical field with knowledge of FDA, EU, and other regulatory body regulations. A different combination of education and experience may be considered.
Certification: Regulatory Affairs Certification (RAC) preferred. AATB CTBS preferred.
Skills: Excellent verbal and written communication, Microsoft Office Suite, Technical writing.
Travel: N/A
Requirements
- Bachelor's degree
- 6+ years of experience as a regulatory specialist in a relevant medical device or pharmaceutical field
- Knowledge of FDA, EU, and other regulatory body regulations
- Excellent verbal and written communication
- Microsoft Office Suite
- Technical writing
Benefits
- Paid Time Off
- 401(k) Matching
- Holiday Pay
- Medical, Dental & Vision
- Short & Long-Term Disability
- Paid Parental Leave
- Annual Bonus up to $10,000
Company overview
Evergen is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in regenerative medicine solutions. Founded in 1998 and headquartered in Alachua, Florida, the company operates as a strategic partner to Original Equipment Manufacturers (OEMs) across multiple medical specialties including plastic and reconstructive surgery, sports medicine and orthopedics, neuro/spine, and cardiac applications. Evergen distinguishes itself as the only regenerative medicine CDMO offering a comprehensive portfolio of both allograft and xenograft biomaterials at scale, providing customers with unbiased, needs-driven solutions. The company maintains over 280,000 square feet of cutting-edge medical device manufacturing space worldwide, featuring Class 5-7 clean rooms and Class III PMA-ready facilities. With ISO 13485 certification and FDA/USDA registration, Evergen delivers end-to-end services spanning research and development, regulatory support, manufacturing, and supply chain management. The company's patient-first approach focuses on developing customized biomaterial solutions that promote healing, accelerate recovery, and prevent complications, positioning Evergen as a trusted partner in advancing regenerative medicine technologies.