Oyster Medisafe Pvt. Ltd., a leading name in the medical device industry, is currently seeking a dedicated and skilled Executive for Quality Assurance & Regulatory Affairs. This exciting opportunity is based in Hyderabad, India, and involves a hands-on role in ensuring compliance, maintaining quality systems, and liaising with regulatory authorities.
About Oyster Medisafe Pvt. Ltd.
Oyster Medisafe Pvt. Ltd. is committed to delivering high-quality medical devices that meet global standards. With a focus on innovation, compliance, and customer satisfaction, the company has established itself as a trusted name in the industry. Our team thrives on ensuring every product aligns with stringent regulatory standards, ensuring safety and efficacy for end users.
Responsibilities in the Role
As an Executive – Quality Assurance & Regulatory Affairs, you will play a pivotal role in maintaining quality and regulatory compliance. Key responsibilities include:
- Regulatory Compliance
- Ensure adherence to ISO 13485, CE marking, EU MDR, and Indian Medical Device Rules.
- Documentation Management
- Act as the document controller, overseeing digital quality and regulatory documentation.
- Quality Systems
- Implement and maintain Good Manufacturing Practices (GMP) and quality management systems.
- Liaison with Authorities
- Engage with drug authorities and regulatory bodies to secure certificates and licenses.
- Audits and Inspections
- Prepare for and assist during internal and external audits.
- Training and Development
- Conduct training sessions for staff on quality and regulatory compliance.
- Continuous Improvement
- Identify opportunities to enhance processes and implement improvements.
- Artwork Management
- Create or update printing artworks to meet regulatory requirements in collaboration with service providers.
Qualifications and Experience
To excel in this role, the ideal candidate must have:
- Education:
- A Bachelor’s degree in Bio Engineering, Life Sciences, Engineering, or Quality Management.
- Experience:
- A minimum of 3–5 years in quality and regulatory affairs, preferably in the medical device or pharmaceutical sectors.
- Certifications:
- Internal auditor certification in ISO 13485 is preferable. Awareness of Indian Medical Device Rules and EU Medical Device Regulations is highly desirable.
Key Skills
- In-depth understanding of ISO 13485, CE marking, and EU MDR 2017/745.
- Proficiency in digital documentation management systems.
- Strong communication and interpersonal abilities.
- Attention to detail and accuracy.
- A proactive approach to problem-solving and process improvement.
