Sr. Regulatory Specialist
Evergen• Remote, Remote, US, Remote
•$100,000 - $115,000•Remote
About The Position
Evergen is hiring a Sr. Regulatory Specialist to provide regulatory support for product development and help ensure that product labeling, advertising, promotional materials, and development documentation meet applicable regulatory requirements. The role includes assessing the effects of global regulatory and product changes, maintaining assigned metrics, supporting audits, and working with internal and external stakeholders to support business needs and quality objectives. The position is remote and includes a stated annual bonus opportunity of up to $10,000.
Requirements
- Bachelor’s degree.
- At least 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.
- Excellent verbal and written communication skills.
- Microsoft Office Suite skills.
- Technical writing skills.
- A different combination of education and experience may be considered.
Nice To Haves
- Regulatory Affairs Certification (RAC).
- AATB CTBS.
Responsibilities
- Lead regulatory support for product development teams, including preparing regulatory opinion documents; coordinating labeling activities; and reviewing and approving design control documentation, risk management reports, technical protocols and reports, and other product development outputs.
- Develop, review, and approve labeling, advertising, and promotional materials to ensure consistency with approved claims and regulatory requirements.
- Maintain awareness of global regulatory and product changes and lead assessments of their impact.
- Maintain assigned metrics, including preparing, tracking, and trending reports; supporting audits; and providing timely stakeholder feedback.
- Develop and maintain effective working relationships with internal and external stakeholders to support business needs.
- Support company and departmental quality and business objectives and initiatives.
- Report on assigned project metrics and provide timely feedback to stakeholders.
- Perform other duties as assigned.
Benefits
- Paid Time Off (PTO).
- 401(k) match.
- Holiday pay.
- Medical, dental, and vision insurance.
- Short-term and long-term disability coverage.
- Paid parental leave.
- Annual bonus opportunity up to $10,000.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
