Job Title: Regulatory Compliance Officer – Medical Devices
Location: Chandigarh
Department: Regulatory Affairs / Quality Assurance
Experience: minimum 3 years
Job Type: Full-time
Job Summary:
We are seeking a detail-oriented and knowledgeable Regulatory Compliance Officer to ensure our medical devices meet all applicable regulatory requirements and standards. The ideal candidate will play a critical role in overseeing compliance activities, preparing regulatory submissions, and collaborating with cross-functional teams to maintain product and process integrity throughout the device lifecycle.
Key Responsibilities:
- Monitor and interpret evolving regulations, standards, and guidance relevant to medical devices (e.g., FDA, ISO 13485, MDR).
- Ensure organizational practices and product development comply with national and international regulations.
- Prepare, review, and submit regulatory documentation including device registrations, licenses, and clinical trial applications.
- Act as a liaison with regulatory authorities and provide updates to internal teams.
- Maintain thorough documentation of all regulatory activities, including correspondence, submissions, and audit records.
- Identify potential compliance risks and implement mitigation strategies.
- Conduct internal training sessions on regulatory standards and updates.
- Participate in internal and external audits; ensure implementation of corrective actions.
- Manage post-market surveillance activities, including adverse event reporting and trend analysis.
- Design and implement regulatory compliance programs and standard operating procedures (SOPs).
Required Skills and Competencies:
- Strong analytical and problem-solving abilities to interpret regulatory requirements.
- Excellent communication skills for effective interaction with regulatory agencies and internal stakeholders.
- High attention to detail and strong organizational skills.
- In-depth knowledge of regulatory standards and frameworks (e.g., US FDA 21 CFR, ISO 13485, EU MDR).
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Strong understanding of medical device lifecycle, development, and manufacturing processes.
- Proficient in MS Office and regulatory document management tools.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related discipline.
- Experience in the medical device industry, specifically in regulatory affairs or quality assurance.
- Demonstrated understanding of regulatory submission processes and documentation.
- Certifications in regulatory affairs (e.g., RAC) are a plus.
To Apply:
Send your updated resume to hr@sysmed.co.in
For more information, contact +91 90566 99984