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Regulatory Affairs Specialist
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Key responsibilities (please specify if the position is an individual one or part of a team):  | This is a position in the TCS team delivering Regulatory Affairs solutions.The candidate will need to have effective team management skills with cross-functional teams working on this project being located remotely.The candidate will be responsible for the following Provide full support to all registration activities, CE marking and regulatory submissions as directed by project requirements. Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies. Establish and maintain processes for submissions, interim notifications and periodic re-submissions. In conjunction with other departments, ensure that post marketing surveillance responsibilities are fulfilled and support vigilance activities. Maintain information on worldwide regulatory requirements and the status of product registrations. Liaise with all departments and project teams to co-ordinate timely applications for CE marking and other approvals. Keep abreast of developments in worldwide regulatory environments, and to address regulatory requirements as appropriate. Review technical documentation created by teams based remotely and ensure these are complete and accurate. Effectively translate customer requirement into logical inputs for teams based remotely, including TCS offshore team. Be responsible for adherence to timelines and ensure milestones are achieved. Report issues to the Customer and TCS management to ensure appropriate closure.
- Supervisory / Managerial responsibilities (please specify if the position will have persons reporting to it): | The candidate will not have direct reportees. He/she will, however, need to have some supervisory skills as being Senior RA specialist he/she will be responsible for meeting required timelines & proper usage of the TCS offshore model.
Key Skills/Knowledge: | Good relevant experience in Medical Device Regulatory Affairs, preferably in Orthopaedics. Experience with EU, FDA and global regulations and requirements on product submissions, re-certifications and remediation. Regulatory Affairs certification (like RAC) preferable. Proficient with MS Office applications such as MS Word, PowerPoint, Excel. Candidate should possess strong communication and inter-personal skills. Candidate must be flexible to accommodate additional effort needed to meet project and organizational deadlines.
Experience required: | Good relevant experience in Regulatory Affairs, preferably in Medical Devices. EU, FDA and global regulations CE renewal Regulatory Affairs certification (like RAC) preferable Must possess a graduate engineering/science degree.

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