Address Responsibilities:
- Regulatory Compliance:
Ensure adherence to regulatory requirements for In Vitro Diagnostics in accordance with MDR 2017.
Stay updated on regulatory changes and effectively communicate their impact on the organization.
- Geographical Oversight:
Responsible for Regulatory Affairs activities in India, with extended coverage to neighboring countries and ASEAN.
Navigate regulatory landscapes to facilitate product registrations and approvals.
- Certification and Qualification:
Knowledgeable in the acquisition of CE Marking, USFDA approval, and WHO qualification for IVD products.
Facilitate and oversee the regulatory processes for obtaining necessary certifications.
- Liaison and Collaboration:
Build and maintain effective relationships with regulatory bodies, including but not limited to Gujarat FDCA, CDSCO, ICMR, and NIB.
Collaborate with internal teams to ensure regulatory compliance throughout the product life cycle.
- Documentation and Submission:
Prepare and submit regulatory documents, ensuring accuracy and completeness.
Manage regulatory submissions and responses to inquiries from regulatory agencies.
- Risk Management:
Identify and assess regulatory risks associated with IVD products.
Develop and implement strategies to mitigate regulatory risks.
- Training and Awareness:
Conduct training sessions for internal teams to enhance regulatory awareness.
Keep the organization informed about changes in regulations and their implications.
- Qualifications:
Bachelor's or Master's degree in a relevant field (Life Sciences, Biotech, Pharmacy or Regulatory Affairs, etc.).
Minimum 6-8 years of experience in Regulatory Affairs, with a focus on In Vitro Diagnostics for the last 3 years.
Thorough knowledge of MDR 2017 and other relevant regulations.
Experience in acquiring CE Marking, USFDA approval, and WHO qualification will be highly preferred.
- Skills:
? Excellent communication and interpersonal skills.
? Strong analytical and problem-solving abilities.
? Detail-oriented with a focus on accuracy in documentation.
? Ability to work collaboratively in a cross-functional team environment.
