Senior Regulatory Specialist (Remote) – Reg Affairs Leader

Evergen; Oregon; Hybrid; USD 110.000 - 170.000; Vollzeit

Benefits dieser Stelle

PTO

401(k) match

Holiday pay

Medical insurance

Dental insurance

Vision insurance

Short-term disability

Long-term disability

Parental leave

Zusammenfassung

Evergen, a global CDMO in regenerative medicine, seeks an experienced Regulatory Affairs Specialist to support product development and ensure compliance with FDA, EU, and international regulations. A Bachelor's degree and 6+ years of regulatory experience are required for this full-time, remote role.

You will lead labeling reviews, prepare regulatory submissions, monitor regulatory changes, and collaborate across teams to drive timely, compliant decisions while supporting Evergen's growth and

Qualifikationen

• Bachelor's degree required.
• 6+ years regulatory experience in medical device or pharmaceutical.
• Knowledge of FDA, EU and global regulatory requirements.

Aufgaben

• Leads regulatory support to product development teams, including preparation of regulatory opinion documents and design control documentation.
• Develops, reviews, and approves labeling, advertising, and promotional material to ensure regulatory compliance.
• Maintains awareness of global regulatory and product changes and assesses impact.
• Ensures assigned metrics are tracked, reports prepared, and audits supported.

Kenntnisse

Excellent verbal and written comms

Microsoft Office Suite

Technical writing

Ausbildung

Bachelor's degree

Jobbeschreibung

Evergen, a global CDMO in regenerative medicine, seeks an experienced Regulatory Affairs Specialist to support product development and ensure compliance with FDA, EU, and international regulations. A Bachelor's degree and 6+ years of regulatory experience are required for this full-time, remote role.

You will lead labeling reviews, prepare regulatory submissions, monitor regulatory changes, and collaborate across teams to drive timely, compliant decisions while supporting Evergen's growth and