Sr. Regulatory Specialist

Evergen; United States; Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Paid Time Off (PTO)

401(k) match

Holiday pay

Medical, dental, and vision insurance

Disability coverage

Parental leave

Job summary

Evergen, a global CDMO in regenerative medicine, is seeking a Regulatory Affairs Specialist to lead regulatory support for product development, labeling coordination, and compliance across FDA, EU, and other authorities. The role includes maintaining metrics, supporting audits, and collaborating with stakeholders across sites.

The ideal candidate has 6+ years in regulatory roles for medical devices or pharmaceuticals, with a Bachelor’s degree and RAC/CTBS preferences.

Qualifications

• Bachelor’s degree required in a related field.
• 6+ years of experience as a regulatory specialist in medical device or pharmaceutical.
• Regulatory affairs certification (RAC) preferred; AATB CTBS preferred.

Responsibilities

• Leads regulatory support to product development teams, including preparation of regulatory opinion documents and labeling coordination.
• Develops and approves labeling and promotional materials to ensure regulatory compliance.
• Monitors global regulatory changes and assesses impact on products and processes.
• Maintains metrics, prepares reports, supports audits, and communicates with stakeholders.
• Builds effective relationships with internal and external stakeholders to support business needs.
• Supports quality objectives and initiatives and reports project metrics.

Skills

Regulatory knowledge

FDA regulations

EU regulations

Regulatory writing

Education

Bachelor's degree

Tools

Microsoft Office

Job description

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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.

Location: Remote

Annual Bonus Opportunity up to $10,000

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.

Our Comprehensive Benefits Package Includes

• 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!

Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://www.linkedin.com/company/evergenbio

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

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

Physical Requirement

• 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.)

Working Environment

• Onsite: Office environment with assigned workstation
• Remote positions only: Home office environment with minimum distractions

More About Evergen

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.

At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.