Senior Regulatory Affair Professional
5 days ago
Job Description
EPM Scientific is hiring a skilled Principal Regulatory Affairs Specialist to join our dynamic team. The ideal candidate will have extensive experience in medical device regulatory affairs and a proven track record of delivering results.
Main Responsibilities:
- Develop and implement global regulatory strategies for new and modified products, ensuring compliance with international regulations.
- Create and submit high-quality regulatory submissions to FDA and international agencies, meeting submission requirements and deadlines.
- Collaborate with internal stakeholders, external authorities, and cross-functional teams to ensure seamless audit and inspection processes.
- Maintain accurate and up-to-date records of annual licenses, registrations, and listing information, adhering to regulatory standards.
- Act as SME for audits and inspections, providing authoritative guidance and support to team members.
- Review and edit promotional materials to ensure compliance with regulatory requirements.
- Analyze and stay current with pertinent medical device regulations worldwide, updating relevant databases and file systems.
- Support product implementation through database license creation or review/approval of release requests, ensuring timely market access.
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