Regulatory Affairs Coordinator
The Regulatory Affairs Coordinator provides international regulatory expertise and support throughout the lifecycle of products manufactured and distributed by EMS for their successful registration in worldwide markets and supporting sales plans. As part of the Regulatory Affairs Group within the Quality department, the Regulatory Affairs Coordinator acts independently and as a team player in the completion of product registrations and the promotion of compliance to applicable regulatory requirements.
Product registration submissions :
- Create a network of support including internal colleagues, distributors and consultants, to provide technical expertise during preparation of submission and in case of requests from authorities during the registration process.
- Coordinate, communicate and collaborate effectively within the network to ensure the optimal completion of the product registrations.
- Identify the appropriate documentation to meet registration needs for product submissions. Create the submission file and any other documentation required to complete the submission or support the distributor / consultant by providing required information and documentation.
- Provide an effective follow-up during the registration process to ensure the completion of the product registration.
- Identify and communicate any potential for improvements in view to reducing the time to market. Share lessons learned from registration projects and update instructions accordingly
Regulatory vigilance :
- Acquire up-to-date information relating to the international regulatory and technical requirements for product registrations.
- Analyse, interpret and communicate international regulatory requirements in view to identifying actions to support registration activities and maintain regulatory compliance of EMS products.
Regulatory expertise :
- Provide support to internal and external clients by answering requests for regulatory information and advice in a timely manner.
- Perform feasibility evaluations, provide regulatory strategy evaluations for development projects in view to reducing time to market.
- Regulatory review of technical documentation including test reports, brochures.
- Offer support to improvement projects.
- Product life cycle management
- Provide support for product change requests and new standards by evaluating and documenting impact, by defining action plans (including retesting) and performing registration updates, so that EMS products continue to be manufactured according to current regulatory, quality and technical standards.
Administrative and soft skills :
- Effective management of ERP, documentation, excel, Key Performance Indicators (KPIs).
- Good client management.
- Back-up and team member support.
Quality support activities :
- Provide support to quality audits.
- Participate in working groups as part of continuous improvement of quality system.
- Contribute to revision of standard procedures
Technical Skills :
- Knowledge of applicable medical device regulatory requirements worldwide.
- Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.
Interpersonal Skills :
- Good oral and written communication skills English– ability to work on cross-functional teams.
- Good organization skills including planning, follow-up and communication of task status.
- Self-motivated by working independently and able to take ownership of his/her responsibilities, and to work under time pressure, and to organize various projects in a timely manner.
- Ability to interact proactively and provide counsel and expertise to internal and external customers.
Take your career to the next level – apply today to :
Please apply with a cover letter and CV in English .
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