What are the responsibilities and job description for the Regulatory Affairs Specialist position at Tephra Inc.?
Description :
The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory submissions. Assist in the creation of technical documentation (technical files and design dossiers) for Spine products that will meet the requirements of the new Medical Device Regulation (MDR) in the European Union. The requirement is for 3 Regulatory Affairs Specialist.
Responsibilities :
- Identify reference documents for technical documentation including, but not limited to design and risk documents, verification / validation documents, standards conformance, and labeling.
- Identify and adhere to policies, procedures and work instructions which support technical documentation activities.
- Provide support for Clinical Evaluation Reports including references to required documentation.
- Align technical documentation according to OneMD technical documentation structure proposed by the MDR team.
- Prepare technical documentation for submission to and reviewed by Notified Bodies, as required.
- Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
- Maintain information on worldwide regulatory requirements and the status of product registrations.
- Be responsible for adherence to timelines and ensure milestones are achieved.
- Report issues to the Customer and Our Client management to ensure appropriate closure.
- Work with Our client teams at offshore and at other geographies.
Qualifications :
Experience Required :
Generic Managerial Skills :
Education :
Bachelor of Engineering (Mechanical, Biomedical preferred) or Bachelor of Science (Biology or Chemistry)
