Regulatory Affairs Specialist
The company is a leading medical device and technology company, that focus on making health care better. The Company offers various advanced medical technologies and devices, including medical and surgical, and neurotechnology and spine products to help better people's lives. Our clients products are available world wide.
Role: Regulatory Affairs Specialist
- Supports new product development for release by contributing to the development and updating of regulatory strategy based upon regulatory changes.
- Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product approvals by FDA, Notified Bodies, and other regulatory bodies.
- Developing and applying basic knowledge and understanding of the regulatory frameworks, regulatory requirements, legislation, processes and procedures.
- Assisting in SOP development and review.
- Providing regulatory input for and appropriate follow-up to inspections and audits.
- Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements.
- participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.
- B.Sc in Engineering, Sciences or equivalent preferred.
- 1-3 years regulatory experience in the medical device or pharmaceutical industry.
- Knowledge of the Quality System Regulations (21 CFR).
- Ability to work with cross functional teams.
- Ability to negotiate internally and externally with FDA, NB and other regulatory bodies.
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To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales