Regulatory Affairs Director
2 weeks ago
Company Overview
EPM Scientific - Phaidon International is a leading global medical device company seeking a highly skilled Manager of Regulatory Affairs to join their innovative team. This key role involves managing regulatory submissions, including 510(k) filings, and working with both the US FDA and EU EMA to ensure compliance with regulatory standards.
Salary: The estimated salary for this position is $120,000 per annum, depending on location and experience.
Job Description
The Manager will collaborate with cross-functional teams to develop and execute regulatory strategies, prepare high-quality documentation, and support product development efforts. This position offers an exciting opportunity to contribute to the advancement of cutting-edge medical technologies that improve patient outcomes worldwide.
- Offering guidance, leadership, and coaching to Regulatory Affairs (RA) Associates.
- Providing expert technical advice on regulatory requirements for new products and modifications to existing ones.
- Managing, preparing, and reviewing regulatory submissions, including 510(k) filings and compliance with EU MDR standards.
- Collaborating with departments and cross-functional teams to communicate regulatory strategies effectively.
- Evaluating advertising and promotional materials to ensure alignment with local and international regulations.
Required Skills and Qualifications
The ideal candidate will hold a bachelor's degree in engineering or physical/biological sciences, with 8 years of experience in Regulatory Affairs, including 1+ year of direct or indirect management experience.
Benefits
This role offers a competitive salary, opportunities for professional growth, and a dynamic work environment.
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