Quality & Regulatory Specialist

Company Description

Meera Consulting Ltd., founded in 2012, is a well-established professional services firm with expertise in Recruitment, Website Design & Development, Digital Marketing, Study Abroad, and HR Consulting. With over a decade of trusted service, the company caters to a diverse clientele across India and globally. Meera Consulting Ltd. is committed to bridging talent and opportunity while delivering tailored solutions marked by precision and reliability. Embracing a modern approach, the firm also excels in guiding businesses toward sustainable operations and assisting individuals in achieving their academic aspirations abroad.

Role Description

We are looking for a QA / RA Specialist – Medical Devices to join our Quality & Regulatory Affairs team in Hyderabad. The ideal candidate will have hands-on experience in Quality Management Systems (QMS), ISO 13485 compliance, Regulatory submissions (FDA 510(k), CE Technical File), and medical device documentation.

If you have a strong background in medical device regulations, risk management, and technical documentation, this is a great opportunity to advance your career in a fast-growing MedTech environment.

Key Responsibilities :

• Implement and maintain Quality Management Systems (QMS) and manage CAPA, Internal Audits, and Nonconformance investigations.
• Prepare and review SOPs, Device Master Records (DMR), and Technical Files.
• Handle Regulatory Filings such as FDA 510(k), CE Technical Files, and CDSCO submissions.
• Support Labeling, UDI, and Post-Market Surveillance (PMS) activities.
• Liaise with Regulatory Authorities and Notified Bodies to maintain global compliance.

Required Skills

Skills Required

Iso 14971, Iso 13485, Regulatory Submissions