| Regulatory Affairs Specialist at Danvers, Massachusetts, USA |
| Email: [email protected] |
| From: Rose Parker, Concord IT Systems Inc [email protected] Reply to: [email protected] Hi Team Hope you are doing good Title : Regulatory (specialist) Location: Danvers, MA/Minneapolis, MN/Mexico/Puerto Rico Duration :Long Term 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: Bachelors 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. Thanks & Regards Rose Parker Concord Id: [email protected] Keywords: information technology container edition Idaho Massachusetts Minnesota Regulatory Affairs Specialist [email protected] |
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| Thu Nov 07 01:03:00 UTC 2024 |