Please find the job details and description below and if interested You can reach me at or call me at +1(732)-813-9025.

Role: Regulatory specialist
Location: Danver,MA / Minneapolis, MN

Job 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.