[Hiring] Sr. Regulatory Specialist @d5d297b8-377e-41ed-bdd6-33f34c6406d3

Role Description

• 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.

Qualifications

• Bachelor’s degree.
• 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.
• Regulatory Affairs Certification (RAC) preferred.
• AATB CTBS preferred.
• Excellent verbal and written communication.
• Microsoft Office Suite.
• Technical writing.

Requirements

• Move or lift objects up to 25 pounds.
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays.
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.).

Benefits

• Paid Time Off (PTO).
• 401(k) match.
• Holiday pay.
• Medical, dental, and vision insurance.
• Short-term and long-term disability coverage.
• Paid parental leave and much more!

Company Description

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN; Eden Prairie and Glencoe, MN; Neunkirchen, Germany; and Marton, New Zealand.

We are proud to be Great Place to Work® Certified in 2026, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.

• Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.
• Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:
• Accountable: We own our actions and decisions.
• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
• Growth Mindset: We embrace challenges as opportunities for continuous learning.
• Customer-Centric: We prioritize customers at every touch point.
• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.