Regulatory Affairs Manager

Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

creation, identification, collection, and entry of regulatory affairs information

Essential Responsibilities

• Create, submit, and maintain product registration requests

  for submission.

• Develop, submit, and manage

  EU MDR, MDSAP, and EN ISO 13485 documents for regulatory compliance.

• Review and approve submission documents

  to ensure compliance with regulatory standards.

• Maintain up-to-date metrics

  with product registration requests and submission schedules.

• Track and monitor regulations

  applicable to medical devices in designated countries.

• Manage and update internal regulatory databases, including licenses and registration records

  .

Qualifications Educational Background

• B.S. degree or higher

  in a technical discipline, preferably in

  Computer Science, Engineering, Bioengineering, Biology, or Chemistry

  .

Professional Experience

• 3-7 years of Regulatory Affairs experience in the medical device industry

  , including international product registrations and new product development.

Knowledge and Skills

Knowledge:

• Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System.

Skills:

• Proficient in Microsoft Word, Excel, and PowerPoint.

• Strong communication skills

  (oral and written) in English.

• Excellent project management skills.

• Ability to manage multiple tasks

  with strong attention to detail.

• Self-motivated and comfortable working remotely with international teams.

• Organized and analytical thinker with problem-solving abilities.



Primary Work Location:

Valsad, Gujarat