Regulatory Affairs Specialist
Concord IT Systems
Title : Regulatory (specialist)
Location: Danvers, MA/Minneapolis, MN/Mexico/Puerto Rico
Long Term CLIENT: Tata Elxsi/Medtronic Description:
Location: Danvers, MA/Minneapolis, MN/Mexico/Puerto Rico
Long Term CLIENT: Tata Elxsi/Medtronic Description:
- Regulatory Submissions: Prepare and submit regulatory documents to agencies such as the FDA, EMA, and other global regulatory bodies.
- Regulatory Compliance: Ensure all products comply with relevant regulations, including FDA 21 CFR 820, ISO 13485, and CE marking requirements.
- Risk Management: Conduct risk assessments and develop mitigation strategies to ensure regulatory compliance.
- Quality Management System (QMS): Support the maintenance and improvement of the QMS to ensure ongoing compliance with regulatory standards.
- Clinical Trials: Oversee regulatory aspects of clinical trials, ensuring compliance with applicable regulations.
- Post-Market Surveillance: Monitor and report on the safety and effectiveness of medical devices after they are released to the market.
- Regulatory Strategy: Develop and implement regulatory strategies to support product development and market access.
- Document Control: Manage regulatory documents to ensure accuracy, completeness, and accessibility.
- Regulatory Inspections: Prepare for and manage regulatory inspections and audits.
- Global Regulatory Compliance: Ensure compliance with international regulations and standards.
- Education : Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
- Experience : Minimum of 3-5 years of experience in regulatory affairs within the medical device industry.
- Knowledge : Strong understanding of FDA 21 CFR 820, ISO 13485, CE marking, and global regulatory requirements.
- Skills : Excellent problem-solving, communication, and project management skills.
- Certifications : Relevant certifications (e.g., Regulatory Affairs Certification (RAC)) are a plus.
Vacancy posted 3 days ago
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