Are you a skilled professional in medical writing or regulatory affairs looking to advance your career in the MedTech industry? RegTrac, a leading healthcare regulatory partner based in Chennai, Tamil Nadu, is hiring a Medical Writing – Regulatory Associate to support global MedTech clients. This full-time, on-site role offers an exciting opportunity to work on CE/UKCA submissions, clinical evaluations, and ISO/QMS standards while collaborating with dynamic teams. If you have 2–3 years of experience in regulatory affairs or medical writing and a passion for compliance and innovation, this role is for you. Read on to learn how to position yourself as a top candidate for this rewarding opportunity.
Responsibilities
As a Medical Writing – Regulatory Associate at RegTrac, you will play a pivotal role in ensuring compliance with global regulatory standards for medical devices, cosmetics, and consumer products. Your key responsibilities include:
- Regulatory Affairs:
- Prepare and manage technical files for CE/UKCA submissions in Europe.
- Lead clinical and medical writing projects, including Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP).
- Support manufacturers by resolving regulatory document queries and providing actionable solutions.
- Stay updated on evolving regulatory requirements and train internal teams to ensure compliance.
- Collaborate with sales teams to develop solutions and proposals for client projects.
- Quality Management Systems (QMS):
- Author, review, and approve QMS procedures to meet ISO 13485, ISO 10993, and ISO 14971 standards.
- Monitor quality processes and provide guidance to maintain compliance with industry standards.
- Support internal and external audits, including supplier/customer audits, in collaboration with the QA team.
- Training and Development:
- Create web-based and in-person training materials for regulatory topics tailored to client needs.
- Develop user guides and documentation to support regulatory training programs.
- Oversee training strategies to ensure comprehensive regulatory knowledge across the organization.
- Client Relationship Management:
- Build and maintain strong client relationships through regular feedback sessions.
- Coordinate cross-departmental efforts to meet project-specific requirements.
Qualifications
To excel in this role, candidates should meet the following requirements:
- Education: Postgraduate degree in life sciences or equivalent.
- Experience: 2–3 years of experience in medical writing or regulatory affairs within the medical device industry.
- Skills:
- Expertise in EU MDR, clinical evaluations, and ISO/QMS standards (ISO 13485, ISO 10993, ISO 14971).
- Excellent written and oral communication skills for engaging with regulatory authorities and stakeholders.
- Strong analytical skills and attention to detail for interpreting regulations.
- Self-motivated, process-driven, and able to work collaboratively in a team environment.
- Proven organizational skills and the ability to manage multiple projects effectively.
Benefits
RegTrac is committed to fostering a supportive and inclusive workplace. By joining our team, you’ll enjoy:
- Career Growth: Opportunities for career progression and specialized training in regulatory affairs.
- Supportive Culture: Engaged management and a peer recognition and rewards program.
- Diverse Environment: A workplace that values diverse perspectives and promotes a sense of belonging.
- Impactful Work: Contribute to global MedTech innovation by ensuring regulatory compliance.
How to Apply
