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 (From East Coast Only)

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.

#countryUS