Regulatory affairs specialist
Updated: 05 Sep 2022
Offered by:Swissels Engineering & Life Science Services
REGULATORY AFFAIRS SPECIALISTThe Regulatory Affairs Specialist provides international regulatory and technical expertise , support throughout the lifecycle of products manufactured and distributed by the compagny 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 Specialist acts independently and as a team player in the completion of regulatory strategy, product registrations and the promotion of compliance to applicable regulatory requirements.Regulatory Strategy:- Develop the optimal regulatory strategy, according to the marketing plans, manage the project and resources, ensure 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.- •Answer specific technical questions from the authorities on the application of various international requirements (directives, standards, etc.) and promote the testing performed to demonstrate compliance.- •Provide technical expertise for registration files in the form of technical reports, summaries and advice- 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.Regulatory expertise :- Provide input for Clinical Evaluation Plan and Reports, Risk Management, Labeling.- Act as an expert for all biological aspects of products delivered sterile.- 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 and registration updates.Administrative and soft skills :
- Effective management of ERP, documentation, excel, Key Performance Indicators (KPIs).
- od 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 the creation and revision of standard procedures by offering regulatory inputs.
- Promote quality and regulatory compliance.profil : Bachelor’s degree / experience in the medical device industry.
Education in Biology, Medical Biology and or Life Science
International regulatory experience with medical device registrations and kledge of international standards and regulations.
Experience working with international businesses or cultures.
Working kledge of electronic documentation and information systems