Senior Regulatory Specialist — Remote with $10k Bonus

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

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.