Regulatory Affairs (RA) Head

About Us

Care Groups operations involve the development and manufacturing of intraocular lenses and associated ophthalmic medical devices & ophthalmic pharmaceuticals. We are dedicated to leveraging cutting-edge technology and stringent quality standards to deliver innovative healthcare solutions globally, ultimately focusing on improving patient outcomes. Our operations demand a commitment to the highest international standards of quality and regulatory compliance.

The Role:

This role demands a strategic leader with deep technical expertise in medical device and/or pharmaceutical regulations, particularly concerning implantable medical devices or sterile injectable formulations. You will be the primary liaison with global regulatory bodies, CDSCO and lead our compliance efforts across domestic and key international markets.

Key Responsibilities:

• Global Regulatory Strategy & Submissions:

  Develop and implement effective regulatory strategies for new and existing implantable medical devices and/or injectable formulations across key global markets. Oversee the preparation, compilation, and submission of regulatory dossiers (CTD/eCTD, Technical Files, and Design Dossiers) to global health authorities.

• International Regulatory Expertise (Mandatory):

  Ensure rigorous adherence to diverse global regulatory frameworks, including EU- MDR, PMDA and MDSAP member markets

• Agency Liaison & Inspections:

  Establish and maintain strong working relationships with regulatory agencies (e.g., EU Notified Bodies, PMDA, KFDA, TGA, etc.). Act as the primary lead for all external regulatory inspections and audits, managing responses and follow-up actions.

• Regulatory Intelligence & Policy

  : Monitor and interpret evolving global regulatory landscapes and standards (e.g., ISO 13485:2016, ISO 14971). Translate new requirements into actionable internal policies and procedures in collaboration with the QA team.

• Post-Market Surveillance & Vigilance:

  Ensure timely execution of robust post-market surveillance (PMS) activities, clinical performance reports (GSPR), vigilance reporting, and Materiovigilance in compliance with global standards.

• Risk Management Oversight:

  Provide regulatory leadership and final approval on product and compliance risk assessments (ISO 14971), ensuring identified risks are acceptable to relevant regulatory bodies.

Required Qualifications & Experience

• Experience: A minimum of 8+ years of progressive experience in Regulatory Affairs within the medical device or pharmaceutical/sterile formulations industry is essential, with at least 3 years in a leadership role.
• Specialized Product Experience: Prior hands-on experience with implantable medical devices or sterile injectable/ophthalmic formulations is mandatory.
• Regulatory Acumen: A proven track record of successful multi-country regulatory submissions and approvals involving the listed global frameworks (MDR, MDSAP, PMDA, KFDA, TGA).
• Education: Masters degree in a relevant scientific, or regulatory discipline.
• Skills: Excellent leadership, strategic thinking, and negotiation skills. Ability to manage complex projects and communicate effectively with global health authorities and internal stakeholders.