What are the responsibilities and job description for the Regulatory Affairs Associate position at TekOne IT Services Pvt. Ltd.?
Job Title: Regulatory Affairs Associate
Key Responsibilities
Key Responsibilities
- Prepare and submit regulatory documentation and submissions, including 510(k) premarket notifications, PMA applications, CE mark submissions, and other regulatory filings.
- Ensure compliance with local and international regulations, including FDA, EU MDR, ISO, and other relevant standards.
- Assist in the preparation of regulatory strategies and submission plans for new and existing products.
- Review and approve labeling, promotional materials, and product documentation to ensure compliance with regulatory requirements.
- Monitor and interpret regulatory changes and updates, and communicate relevant information to cross-functional teams.
- Coordinate with internal teams, including R&D, Quality Assurance, and Manufacturing, to ensure regulatory requirements are met throughout the product lifecycle.
- Participate in regulatory audits and inspections, and support the preparation and management of audit responses.
- Maintain accurate and up-to-date records of regulatory submissions, approvals, and correspondence.
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- 2 years of experience in regulatory affairs within the medical device industry.
- Knowledge of FDA regulations (21 CFR), EU MDR, ISO 13485, and other relevant standards.
- Strong analytical skills and attention to detail.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
