Senior Regulatory Specialist

🕒 October 20

🇺🇸 United States – Remote

💵 $100k - $115k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Evergen (Formerly RTI Surgical)

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1998

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Evergen is a world-class Contract Development and Manufacturing Organization (CDMO) with a 25-year history of innovation in regenerative biomaterials. Formerly known as RTI Surgical, Evergen partners with innovative companies to accelerate the design, development, and manufacturing of life-changing regenerative medicine therapies. Their commitment to quality and safety has led to over 17 million life-enhancing implants, reflecting their dedication to providing patient-centric biomaterial solutions for effective healing.

📋 Description

• Lead regulatory support for product development teams • Prepare regulatory opinion documents • Coordinate labeling activities • Review and approve design control documentation, risk management reports, technical protocols and reports, and other product development outputs • Develop, review, and approve labeling, advertising, and promotional materials for consistency with approved claims and regulatory requirements • Monitor global regulatory and product changes and lead impact assessments • Maintain assigned metrics, including preparing, tracking, and trending reports • Support audits and provide timely stakeholder feedback • Develop and maintain effective relationships with internal and external stakeholders • Support company and departmental quality and business objectives and initiatives • Report on assigned project metrics • Perform other duties as assigned

🎯 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 • Regulatory Affairs Certification (RAC) preferred • AATB CTBS preferred • Excellent verbal and written communication • Microsoft Office Suite • Technical writing • Ability to 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.) • Remote positions require a home office environment with minimum distractions

🏖️ Benefits

• Annual bonus opportunity up to $10,000 • Paid Time Off (PTO) • 401(k) match • Holiday pay • Medical, dental, and vision insurance • Short-term and long-term disability coverage • Paid parental leave • Remote work arrangement • Great Place to Work® certified workplace culture

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