RegTrac
Website:
reg-trac.com
Job details:
Company Overview
RegTrac is a leading healthcare regulatory partner specializing in Global Regulatory Affairs, Quality Systems, and Compliance for Medical Devices, Cosmetics, and Consumer Products. With expertise in navigating regulatory requirements across diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success.
Role description
We are seeking a highly motivated Regulatory Affairs Associate to join our dynamic team in Chennai. In this role, you will play a critical part in ensuring regulatory compliance for our medical device products throughout their lifecycle. You will collaborate with cross functional teams, including R&D, Quality Assurance, and Marketing, to support product development, regulatory submissions, and global market access.
Key Responsibilities
- Prepare and submit regulatory submissions for medical devices including 510(k)s, and eSTAR applications, ensuring compliance with FDA and international regulatory standards.
- Conduct comprehensive reviews of product labeling, promotional materials, and technical documentation to ensure alignment with regulatory guidelines.
- Monitor, interpret, and communicate changes in global regulatory requirements and trends, providing strategic guidance to internal stakeholders.
- Establish and maintain effective communication with regulatory agencies, including the US FDA, to address inquiries, audits, and information requests.
- Develop and implement regulatory strategies for new product development, market entry, and post-market surveillance activities.
- Collaborate with cross-functional teams to conduct regulatory compliance training and foster a culture of regulatory awareness within the organization.
- Foster a dynamic working relationship with RegTrac Clients.
Required Qualifications
- Master’s degree in Regulatory Affairs, Life Sciences, Biotechnology, or a related field.
- 2–3 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industries.
- Strong knowledge of FDA regulations and guidelines, with a proven track record of successful regulatory submissions, including 510(k) applications.
- Experience with eSTAR (electronic Submission Template and Review) systems.
- Demonstrated ability to manage regulatory submissions and maintain compliance with international standards.
- Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly to diverse audiences.
Preferred Qualifications
- Advanced degree (Master’s or PhD) in a relevant field.
- Experience with regulatory compliance in multiple regions, including the EU, Canada, or Asia-Pacific. Proficiency with electronic submission systems and regulatory databases.
- Strong analytical skills and attention to detail, with the ability to manage multiple projects simultaneously. Certification in Regulatory Affairs (e.g., RAC) is a plus.
Why Join RegTrac?
- Work with a global leader in regulatory affairs, supporting cutting-edge medical technologies.
- Collaborate with cross-functional teams in a dynamic and supportive work environment.
- Opportunities for professional growth and development.
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