Regulatory Affairs Specialist
4 weeks ago
We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at EPM Scientific. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulatory requirements.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with global regulatory requirements
- Prepare and submit regulatory applications to FDA and international agencies
- Coordinate and compile regulatory submissions, including EU dossiers, Premarket notifications, PMA supplements, and change notifications
- Maintain annual licenses, registrations, and listing information
- Act as the subject matter expert (SME) for audits and inspections with internal and external authorities
- Review and edit promotional materials
Requirements:
- Minimum 5+ years of experience with Class II and/or Class III medical devices
- Experience authoring and submitting 510k applications and PMA supplements
- RAC Certification
Preferred Qualifications:
- Experience working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC)
- Strong technical writing skills
- Ability to travel 5%, including international travel
About EPM Scientific:
EPM Scientific is a leading pharmaceutical company with a strong commitment to innovation and quality. We are seeking talented individuals who share our passion for delivering exceptional results and making a meaningful impact in the industry.
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