RegTrac is hiring for the position of Regulatory Affairs Associate – USFDA 510(k) in Chennai. This opportunity is suitable for regulatory affairs professionals with experience in medical device regulatory submissions, USFDA 510(k), eSTAR applications, product compliance, and global regulatory requirements.

RegTrac provides regulatory affairs, quality systems, and compliance services for medical devices, cosmetics, and consumer products. The selected Regulatory Affairs Associate will work with cross-functional teams such as R&D, Quality Assurance, and Marketing to support regulatory submissions, product development, lifecycle compliance, and global market access.

Candidates with a Master’s degree in Regulatory Affairs, Life Sciences, Biotechnology, or a related discipline and relevant regulatory affairs experience can consider this opportunity.

Key Responsibilities

• Prepare and submit USFDA 510(k) regulatory submissions for medical devices.
• Prepare and manage FDA eSTAR applications in accordance with applicable requirements.
• Review medical device product labeling, promotional materials, and technical documentation for regulatory compliance.
• Monitor changes in FDA and international medical device regulatory requirements.
• Interpret new regulatory guidelines and communicate their impact to relevant stakeholders.
• Communicate with regulatory authorities, including the US Food and Drug Administration (FDA), regarding inquiries, audits, and information requests.
• Develop regulatory strategies supporting new medical device development and market entry.
• Support regulatory requirements associated with post-market surveillance.
• Work closely with R&D, Quality Assurance, Marketing, and other cross-functional teams.
• Support regulatory compliance training and promote regulatory awareness within the organization.
• Maintain effective professional relationships with RegTrac clients.
• Support compliance with applicable international medical device regulatory standards.

Qualification & Eligibility

Candidates should possess a Master’s degree in Regulatory Affairs, Life Sciences, Biotechnology, or a related field.

An advanced Master’s degree or PhD in a relevant scientific or regulatory discipline may be preferred for certain responsibilities.

Applicants should have approximately 2–3 years of regulatory affairs experience within the pharmaceutical, biotechnology, or medical device industry.

Skills Required

Candidates applying for the RegTrac Regulatory Affairs Associate job in Chennai should ideally have:

• Strong understanding of USFDA medical device regulations
• Hands-on knowledge of 510(k) submissions
• Experience with FDA eSTAR
• Medical device regulatory submission experience
• Regulatory strategy development
• Technical documentation review
• Product labeling compliance
• Knowledge of international regulatory standards
• Regulatory intelligence and guideline monitoring
• Post-market regulatory knowledge
• Strong analytical and documentation skills
• Excellent written and verbal communication
• Ability to manage multiple regulatory projects
• Cross-functional collaboration skills

Experience with regulatory requirements in regions such as the European Union, Canada, or Asia-Pacific will be advantageous.

Knowledge of electronic regulatory submission systems and regulatory databases is also preferred.

A Regulatory Affairs Certification (RAC) is considered an additional advantage.

What Is USFDA 510(k)?

A 510(k) premarket notification is a regulatory submission used for applicable medical devices seeking US market clearance. The submission generally demonstrates that a new device is substantially equivalent to an appropriate legally marketed predicate device.

For this position, the Regulatory Affairs Associate will support preparation and management of 510(k) documentation and related FDA submission activities.

What Is FDA eSTAR?

eSTAR (electronic Submission Template And Resource) is an interactive submission template used by the FDA for applicable medical device premarket submissions.

Because RegTrac specifically requires experience with 510(k) and eSTAR applications, candidates with practical medical device regulatory submission exposure may have a stronger profile for this position.

Why Join RegTrac?

RegTrac offers professionals an opportunity to work in the specialized field of medical device regulatory affairs and gain exposure to global regulatory requirements.

Key benefits highlighted for the role include:

• Exposure to global regulatory affairs projects
• Opportunity to support innovative medical technologies
• Collaboration with R&D, QA, Marketing, and other functional teams
• Experience with USFDA medical device submissions
• Exposure to global market-access activities
• Professional learning and career-development opportunities
• Dynamic and collaborative working environment

Who Should Apply?

This position is particularly relevant for candidates currently working in areas such as:

Medical Device Regulatory Affairs | USFDA Regulatory Affairs | 510(k) Submissions | eSTAR Submissions | Regulatory Compliance | Medical Device Documentation | Global Regulatory Affairs

Candidates should carefully review the requirement for previous regulatory affairs and 510(k) submission experience before applying.

Application Link