Regulatory Affairs Professional for Medical Devices
1 week ago
Pasona N A, Inc. is seeking an experienced Regulatory Affairs Specialist to join their US team.
This role will focus on preparing and submitting regulatory documentation for new or modified medical devices in the US market.
The ideal candidate will have a strong understanding of FDA regulations and guidelines related to medical devices, with over three years of experience in preparing 510(k) documentation for submissions.
Key Responsibilities:
- Prepare and submit regulatory documentation for new and modified medical devices
- Liaise with RA consultants and the FDA to ensure compliance with regulations
- Develop and implement submission strategies for new products
- Stay up-to-date with the latest legislation, guidelines, and regulations related to regulatory affairs in the US
- Ensure company products conform to applicable medical product regulations
- Monitor expiration dates of licenses and apply for renewals as needed
Requirements:
- Bachelor's degree and a minimum of 3 years of related experience required
- Knowledgeable in FDA regulations relating to medical devices essential
- Effective verbal and written communication skills a must
- Strong interpersonal skills required
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint)
- Ability to travel internationally as required
Salary Estimate:$120,000 - $180,000 per year based on experience
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