An international medical devices manufacturer is seeking a Senior Regulatory Affairs Specialist to join their US team.

This position will primarily be responsible for preparing and submitting regulatory documentation for the marketing of new or modified medical devices, ensuring compliance with US regulations.

This role can be performed remotely, but the candidate must reside in the East Coast such as NJ, NY, MA, CT, DC, MD, or PA.

The ideal candidate will have over three years of direct experience in preparing 510(k) documentation for FDA submissions and in communicating and negotiating with the FDA.

Having Japanese language skills or understanding of Japanese business culture is a significant advantage, as it will facilitate communication with the headquarters in Japan.

• Prepare documentation to file 510k, De Novo, PMA, and Pre-Sub to the FDA and file to the FDA.
• Prepare and submit documentation to respond to additional requirements by the FDA.
• Liaison and negotiate with RA consultants and the FDA.
• Communicate and collaborate with RA members at an HQ in Japan.
• Devise submission strategy for new products to get clearance.
• Keep abreast of legislation, guidelines, and regulations relating to regulatory affairs in the US; inform and advise the team in Japan.
• Ensure that the company's products and related documents conform to the latest appropriate medical product regulations.
• Monitor expiration dates of licenses and apply for license renewals.
• Respond to audits by the FDA as needed.
• Participate in medical, industrial activities, seminars, and conferences for regulatory affairs.

Requirements:

• Bachelor’s degree and a minimum of 3 years of related experience is required.
• Knowledgeable in FDA regulations relating to medical devices required.
• Effective verbal and written communication skills a must.
• Strong interpersonal skills required.
• Proficient in Word, Excel, PowerPoint required.
• Previous direct experience in medical device regulatory affairs required.
• Must be able to travel internationally as required.