If you’re passionate about ensuring organizational compliance with regulations and have expertise in regulatory affairs, Avana Medical Devices Pvt. Ltd. has an exciting opportunity for you! We are seeking a dynamic professional to join our team as a Regulatory Affairs & Compliance Specialist at our Chennai location. This is a full-time role perfect for candidates with 1-3 years of relevant experience.
About Avana Medical Devices Pvt. Ltd.
Avana Medical Devices Pvt. Ltd. is a pioneering company in the medical device industry, dedicated to delivering innovative healthcare solutions. Based in Chennai, India, we focus on developing high-quality medical devices that enhance patient outcomes while ensuring strict adherence to global regulatory standards. Our team is committed to driving innovation, compliance, and excellence in the healthcare industry.
Responsibilities of the Role
Regulatory Affairs
- Prepare, review, and submit regulatory documents, reports, and filings to authorities.
- Ensure timely approvals for products, services, or operations in compliance with applicable regulations.
- Monitor changes in regulatory landscapes and provide strategic advice to the management team.
- Liaise with regulatory authorities for audits, inspections, and inquiries.
Compliance Management
- Develop, implement, and maintain compliance policies, procedures, and controls.
- Conduct internal audits and risk assessments to ensure compliance with laws and regulations.
- Investigate compliance issues or breaches and recommend corrective actions.
- Ensure adherence to ethical standards and organizational policies across all levels.
Documentation and Reporting
- Maintain detailed records of regulatory submissions, licenses, and compliance activities.
- Generate compliance status reports for senior management and stakeholders.
- Prepare documentation for audits, inspections, and regulatory filings.
Training and Awareness
- Deliver training programs to educate employees about regulatory and compliance requirements.
- Promote a culture of integrity and compliance within the organization.
Risk Management
- Identify and assess compliance risks and implement mitigation strategies.
- Conduct compliance audits and investigations, reporting findings to management.
Qualifications and Skills
Required Qualifications
- Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field.
- 1-3 years of experience in regulatory affairs or compliance roles, preferably in the medical industry.
Key Skills
- Strong knowledge of regulatory frameworks, laws, and standards applicable to the medical device industry.
- Proficiency in preparing and managing regulatory submissions and audits.
- Excellent organizational skills with attention to detail for documentation and reporting.
- Strong communication and interpersonal skills to liaise with regulatory authorities and internal teams.
- Analytical mindset to identify and mitigate compliance risks effectively.
