Senior Regulatory Lead — Remote (FDA/EU)

Evergen; West Lafayette, Eden Prairie, Glencoe (IN, MN, KY, FL); Remote; USD 100,000 - 115,000; Full time

Benefits offered by this job

Paid Time Off (PTO)

401(k) match

Holiday pay

Medical, dental, and vision insurance

Short-term and long-term disability

Job summary

Evergen, a global CDMO in regenerative medicine, seeks a Sr. Regulatory Specialist for remote US operations. You will support product development with regulatory submissions, labeling, and compliance across multiple facilities, including West Lafayette, IN, and global sites.

This role requires 6+ years in regulatory affairs in medical devices or pharma and offers strong benefits and a competitive salary. The position emphasizes collaboration with cross-functional teams, coordination of

Qualifications

• 6+ years of regulatory specialist experience in medical device or pharmaceutical fields.
• Knowledge of FDA and EU regulations and other regulatory bodies.
• RAC certification preferred; AATB CTBS preferred.

Responsibilities

• Leads regulatory support for product development and labeling activities.
• Reviews design controls, risk management reports, and regulatory documents.
• Maintains awareness of global regulatory changes and assesses impact.
• Prepares and tracks regulatory metrics, supports audits, and communicates findings.
• Collaborates with internal and external stakeholders to meet business needs.

Skills

Excellent communication

Microsoft Office

Technical writing

Job description

Evergen, a global CDMO in regenerative medicine, seeks a Sr. Regulatory Specialist for remote US operations. You will support product development with regulatory submissions, labeling, and compliance across multiple facilities, including West Lafayette, IN, and global sites.

This role requires 6+ years in regulatory affairs in medical devices or pharma and offers strong benefits and a competitive salary. The position emphasizes collaboration with cross-functional teams, coordination of