[Hiring] Sr. Regulatory Specialist @Evergen

Role Description

• Leads regulatory support to product development teams, including preparation of regulatory opinion documents, coordination of labeling activities and review and approval of design control documentation, risk management reports, technical protocols and reports, and other outputs of product development.
• Develops, reviews, and approves labeling, advertising, and promotional material to ensure consistency with approved claims and regulatory requirements.
• Maintains awareness of global regulatory and product changes and leads impact assessment of changes.
• Ensures assigned metrics are maintained, including preparing, tracking and trending reports, supporting audits, and providing timely feedback to stakeholders.
• Develops and maintains effective working relationships with internal and external stakeholders to support needs of the business.
• Supports company and departmental quality and business objectives and initiatives.
• Reports on assigned project metrics and provides timely feedback to stakeholders.
• Other duties as assigned.

Qualifications

• Bachelor’s degree.
• 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.
• A different combination of education and experience may be considered.
• Regulatory Affairs Certification (RAC) preferred.
• AATB CTBS preferred.
• Excellent verbal and written communication skills.
• Proficiency in Microsoft Office Suite.
• Technical writing skills.

Requirements

• 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.).

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 and much more!