Regulatory Affairs Specialist:

Work location: Delhi

Education

Bachelor's degree in physical/biological sciences or engineering preferred/ M.Pharm, or equivalent of education.

Experience

Minimum 10 years of progressive experience in Regulatory Affairs, including at least 6 years of professional experience in regulatory affairs or quality management systems relating to medical devices. Prior experience in a supervisory or lead capacity required. Must have experience with CDSCO submissions and experience with EU CE marking is preferred.

Skills

- Written and oral communication skills
- Strong negotiation skills
- IT skills, particularly in relation to using databases and familiarity with commercial software The ability to work under pressure and to strict deadlines
- Understanding of both legal and scientific matters
- Team-working skills and the ability to lead and motivate others Project-management skills
- Integrity and a qualified approach to work tact and diplomacy
- An awareness of the legislation governing the approval of products.

Certificates, Licenses, Registrations

Quality Assurance or Regulatory Affairs Certification (RAC) desired

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📌 Regulatory Affairs Specialist (Delhi)
🏢 Artech
📍 Delhi