Regulatory Affair Lead Firenze

Regulatory Affair Lead
Firenze
Toscana, Firenze

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.

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

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

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

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- 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.

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

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

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- 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).