Associate- Quality & Regulatory

Role & responsibilities

We are looking for a detail-oriented Regulatory Affairs Executive to oversee compliance with ISO 13485:2016, ISO 9001:2015, and ISO 27001:2022 standards. The role involves ensuring adherence to regulatory requirements, coordinating audits, managing documentation, and supporting quality management initiatives to maintain certifications.

Key Responsibilities:

• Ensure compliance with ISO 13485 (Medical Devices), ISO 9001 (Quality Management), and ISO 27001 (Information Security) standards.
• Prepare, review, and maintain regulatory documentation, policies, and procedures.
• Coordinate internal and external audits, including liaising with certification bodies and regulatory authorities.
• Assist in the development and implementation of Quality Management Systems (QMS) and Information Security Management Systems (ISMS).
• Monitor regulatory changes and ensure timely updates to company policies and procedures.
• Conduct training sessions to enhance awareness of regulatory and quality standards within the organization.
• Support risk assessment and mitigation strategies related to compliance.
• Maintain records of non-conformities, corrective actions, and preventive measures.
• Work closely with cross-functional teams to ensure product and process compliance with local regulations.

Preferred candidate profile

• Bachelors or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field.
• 1-2 years of experience in Regulatory Affairs, Quality Assurance, or Compliance within the Medical Device, Pharma, or Healthcare industry.
• Strong knowledge of ISO 13485, ISO 9001, and ISO 27001 requirements.
• Experience in handling audits and regulatory documentation.
• Familiarity with QMS and ISMS frameworks.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work collaboratively across departments.