Regulatory Affairs Specialist

Location: Salt Lake, Sector V, Kolkata
Number of Vacancies: 1
Joining: Immediate
Salary Range: ₹30,000 – ₹40,000 per month
Experience Required: 3–5 Years (Minimum)

We are looking for an experienced Regulatory Affairs Specialist to join our team and ensure compliance with global medical device regulations. The ideal candidate will be responsible for preparing and reviewing regulatory documentation, supporting regulatory submissions, and ensuring adherence to international standards such as EU MDR, FDA regulations, and ISO 13485. You will work closely with cross-functional teams to manage regulatory risks, assist in product development processes, and support post-market surveillance efforts.

This role offers an excellent opportunity to build in-depth knowledge of regulatory frameworks and make a meaningful impact in the medical device sector.

Prepare, review, and maintain regulatory documentation including technical files and declarations of conformity.

Assist in regulatory submissions for international markets (EU MDR, FDA 21 CFR Part 820, etc.).

Ensure compliance with ISO 13485, ISO 14971, and applicable standards.

Support internal teams with regulatory guidance during product development and lifecycle management.

Contribute to risk management activities and quality system processes.

Stay up-to-date with changes in global regulatory requirements.

Support post-market surveillance and reporting activities.

Manage UDI, labeling, and market authorization documentation where applicable.

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

3–5 years of experience in regulatory affairs, quality assurance, or compliance in the medical device or related industry.

In-depth understanding of EU MDR, FDA 21 CFR Part 820.

Familiarity with ISO 13485 and ISO 14971 standards.

Hands-on experience in preparing technical files, regulatory submissions, and other compliance documents.

Knowledge of UDI, labeling, and product registration processes (preferred).

Experience with SaMD regulations, EUDAMED, or FDA submissions is a plus.

Understanding of cybersecurity requirements for connected medical devices (preferred).

Excellent analytical and problem-solving capabilities.

Strong verbal and written communication skills.

High attention to detail and documentation accuracy.

Ability to work independently in a fast-paced and deadline-driven environment.

Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management systems.