PR/086557 | Senior Regulatory Affairs Specialist (East-Coast / Full-Remote)

POSITION SUMMARY

The Senior Regulatory Affairs Specialist is responsible for preparing and submitting regulatory documentation for the marketing of new or modified medical devices in accordance with U.S. regulations.

RESPONSIBILITIES 

• Prepare documentation to file 510(k), De Novo, PMA, and Pre-Sub to the FDA and submit to the FDA.

• Prepare and submit documentation to respond to additional requirements by the FDA.

• Liaise and negotiate with regulatory affairs consultants and the FDA.

• Communicate and collaborate with regulatory affairs members in Japan.

• Devise submission strategies for new products to obtain clearance.

• Stay informed about legislation, guidelines, and regulations related to regulatory affairs in the U.S.; inform and advise the team in Japan.

• Ensure that products and related documents conform to the latest medical product regulations.

• Monitor expiration dates of licenses and apply for license renewals.

• Respond to audits by the FDA as needed.

• Participate in medical industry activities, seminars, and conferences related to regulatory affairs.

QUALIFICATIONS

• Bachelor's degree and a minimum of 3 years of related experience.

• Knowledgeable in FDA regulations related to medical devices.

• Effective verbal and written communication skills.

• Strong interpersonal skills.

• Proficient in Word, Excel, and PowerPoint.

• Previous direct experience in medical device regulatory affairs.

• Ability to travel internationally as required.

COMPETENCIES

• Communication proficiency

• Active thinker and actor

• Problem-solving and analysis

• Self-management

• Cooperativeness

SALARY　USD130,000-200,000(Yearly Bonus Included)

LOCATION　Fully Remote Work

We sincerely apologize, but due to a high volume of applicants, only those who successfully pass the initial screening will be contacted. We truly appreciate your understanding.

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