Lead RA Specialist, EMEA (maternity cover)
STRYKER ROMANIA SRL - 1 poziție
- Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes across Europe, Middle East and Africa.
- Provide maturity and significant RA experience and expertise to the EMEA RAQA team to accelerate market access.
- Partner with the business by driving regulatory processes and activities through strategic projects.
- Leads the execution and delivery of the EMEA registration plan for assigned franchises and building high quality regulatory dossiers to achieve timely regulatory approvals and renewals.
- Primary contact with assigned Stryker Design Divisions on market clearance and renewal activities, ensuring ongoing market access in line with business strategy.
- Supports the execution of submission strategies / registration planning in EMEA in collaboration with RAQA management.
- Maintain active participation in product lifecycle management planning and associated RA execution.
- Build, implement and maintain effective product registration processes.
- Partner with International RA teams to promote sharing of best practice and leveraging of product documentation to accelerate market access.
- Analyse and monitor registration activity for all franchises on a periodic basis to ensure performance is in line with objectives and communicate performance to RAQA management.
- Provide regulatory guidance and training to EMEA RAQA colleagues, new starters and Design Divisions as a subject matter expert on EMEA regulations.
- Monitor regulatory changes across EMEA region and wider medical device industry and escalate to RAQA management as necessary.
- Support the training of international Design Divisions in understanding regulatory frameworks, registration requirements and EMEA design inputs for new product development.
- Support Corporate / International projects as required.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years' experience.
Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes
Publicat 20 aug. 2021 Reactualizat 20 sept. 2021 Expiră 30 sept. 2021