Regulatory Affair Lead

**Job Requirements**
- Regulatory Compliance: Ensure that company products and processes comply with relevant regulations, such as FDA (21 CFR Part 820), ISO 13485, EU MDR, IEC 62304 and other global standards.
- ** Analyze the regulatory needs and customer requirements on active medical devices on electrical, mechanical and software components.**:

- ** Responsible to own & lead entire Medical Device for remediation according to customer requirement.**:

- ** Execute the remediation project by assisting the remediation engineers.**:

- ** Review of the artifacts modified or prepared for remediation projects.**:

- Labeling and Packaging: Ensure compliance with labeling and packaging regulations, including content, design, and format requirements.
- Prepare technical documentation dossiers for regulatory submissions, including design controls, risk management plans, and performance testing data.
- Product Development: Collaborate with cross-functional teams to develop new products, ensuring regulatory compliance throughout the product lifecycle.
- Audits and Inspections: Coordinate internal audits and prepare for FDA inspections by ensuring compliance with regulations and maintaining accurate records.
- Compliance Monitoring: Monitor compliance with company policies, procedures, and regulatory requirements, identifying areas for improvement and implementing corrective actions as needed.
- Manage the regulatory submission process for new and existing medical devices, working closely with notified bodies and regulatory agencies.
- Track regulatory timelines and milestones, ensuring timely submissions and approvals.

**Work Experience**
- Bachelor’s / Diploma / Master’s degree in a related field, such as biomedical engineering, Mechanical Engineering, Electrical and Electronics Engineering or related life science.
- 10-12 years of experience in Medical device industry
- Minimum 8 years of experience in medical device regulatory affairs, preferably with experience in the active medical device (Entire life cycle).
- Hands on experience in DHF Gap Assessment and Remediation for FDA 21 CFR Part 820, EU MDR.
- Experience working in Class II or Class III products preferred.
- ** High exposure to prepare/correlate regulatory compliance of active medical devices in full lifecycle.**:

- ** Able to understand the regulatory needs and customer requirements on active medical devices on electrical, mechanical and software components.**:

- ** Strong leadership and mentoring skills, with the ability to guide junior team members and lead cross-functional projects.**:

- Familiarity with computerized systems, such as electronic submission systems (e.g., FDA's eSubmitter).
- Certifications: CRCR (Certified Regulatory Compliance Representative), RAC (Regulatory Affairs Certification), or similar certifications are desirable.
- Strong understanding of technical documentation requirements for medical devices (e.g., design controls, risk management, QMS).
- Excellent communication and project management skills, with the ability to work effectively with cross-functional teams.
- Attention to detail and organizational skills, with the ability to manage multiple projects simultaneously.
- Familiarity with computerized systems, such as electronic submission systems (e.g., FDA's eSubmitter).
- Certifications: CRCR (Certified Regulatory Compliance Representative), RAC (Regulatory Affairs Certification), or similar certifications are desirable.
- Strong understanding of technical documentation requirements for medical devices (e.g., design controls, risk management, QMS).