Sr. Regulatory Specialist
Budget / Salary$100,000–115,000
TypeFull-time job
LocationUnited States
Posted2 hours ago
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:
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
SAFETY
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.
Originally posted on Himalayas
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:
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
SAFETY
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.
Originally posted on Himalayas
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