QA/RA Specialist (Medical Device)

Responsibilities

Support the QA/RA team in maintaining compliance with applicable medical device regulations and standards .

Assist in preparing, reviewing, and maintaining quality and regulatory documentation .

Support preparation and maintenance of technical documentation and regulatory submissions under supervision.

Assist with FDA, EU MDR, UKCA, and other international regulatory requirements , as applicable.

Support risk management activities in accordance with ISO 14971.

Assist with CAPA, nonconformance, complaint handling, change control, and deviation management activities.

Support QMS activities and maintenance of controlled documents and quality records.

Assist in preparing for and supporting internal and external audits .

Conduct basic regulatory research and monitor applicable regulations, standards, and guidance documents.

Collaborate with R&D;, Quality, Manufacturing, and other teams to support regulatory and quality requirements.

Support supplier quality and qualification activities , as required.

Perform document reviews to ensure accuracy, completeness, consistency, and compliance .

Learn and apply applicable medical device regulations, standards, and company procedures.

Qualifications





Bachelor’s or Master’s degree in Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, Quality Assurance , or a related field.

Fresh graduates/0–1 year experience in medical devices, regulatory affairs, or quality assurance are welcome to apply.

Basic understanding of medical device regulatory requirements and quality management systems.

Familiarity with ISO 13485 and ISO 14971 is preferred.

Basic awareness of FDA medical device regulations, 510(k) pathway, EU MDR 2017/745, or UK medical device regulations is an advantage.

Strong written and verbal communication skills .

Good technical writing and documentation skills with strong attention to detail.

Ability to understand and interpret regulations, standards, and technical documents .

Robust analytical and problem-solving skills.

Proficiency in MS Office, particularly Word and Excel .

Ability to work independently as well as collaboratively in a cross-functional team environment .

Strong willingness to learn and build a career in Medical Device Quality & Regulatory Affairs .

Willingness to travel to customer facilities and other locations, as required.

📌 QA/RA Specialist (Medical Device) (Ahmedabad)
🏢 V Reg Solutions
📍 Ahmedabad