Regtrac Solutions (OPC) is a leading regulatory consulting firm that specializes in compliance solutions for medical devices and in-vitro diagnostics (IVDs). The company supports manufacturers in obtaining CE certifications and maintaining quality management systems (QMS) in alignment with global regulatory standards. With a strong focus on European Medical Device Regulation (EUMDR), ISO compliance, and client-centric solutions, Regtrac Solutions helps businesses navigate complex regulatory landscapes.
Job Responsibilities
As a Regulatory Affairs Associate at Regtrac Solutions (OPC), your primary responsibilities will include:
- Authoring, reviewing, and approving relevant procedures as per the required QMS system.
- Maintaining and updating the Quality Management System (QMS) to comply with regulatory standards.
- Preparing technical files and supporting projects for CE Certifications.
- Providing in-house EUMDR support for clients and leading client projects.
- Ensuring compliance with ISO 13485, ISO 10993, and ISO 14971 standards.
- Reviewing and approving medical device labels as per regulatory requirements.
- Assisting clinical teams with Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP).
- Addressing regulatory document-related queries from manufacturers and providing appropriate solutions.
- Managing client relationships and ensuring regular feedback sessions.
- Conducting training on regulatory compliance standards within the organization.
Qualification Requirements
The ideal candidate for this role should have:
- A Master’s/Postgraduate degree in Science (Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, or Pharmacology).
- A minimum of 2 years of experience in Regulatory Affairs within a Medical Device or IVD industry.
- Strong knowledge of EU and international medical device regulations and submissions.
- Experience in analyzing and reviewing documentation in compliance with regulatory guidelines.
- The ability to generate high-quality documentation within strict deadlines.
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Essential Skills
To succeed in this role, candidates should possess:
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- Strong understanding of medical device regulations, including CE certification and EUMDR compliance.
- Excellent communication skills (both written and verbal) for documentation and regulatory submissions.
- Attention to detail and strong analytical skills for reviewing technical files and compliance documents.
- Ability to work independently and in teams within a fast-paced regulatory environment.
- Strong organizational and follow-up skills to ensure compliance with industry standards.
- Problem-solving ability to identify and address regulatory challenges effectively.
Perks and Benefits
- Medical Insurance
- Gratuity
- Bonus
- Hybrid Work Model (Remote Working Available)
