Regulatory Affairs Group Leader

NyonFixe2018-09-14Master / Université
Our client, an international growing medical device, is recruiting a

Regulatory Affairs Group Leader

Your Responsibilities

Main purpose of the role:
As part of the Regulatory Affairs Group within the Quality department, the Regulatory Affairs Group Leader – Medical supports the team members, Group Leaders and Head of Quality to promote compliance of quality system and products.

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.
  • 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 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).
  • 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 the creation and revision of standard procedures by offering regulatory inputs.
  • Promote quality and regulatory compliance by presenting regulatory affairs activities to stakeholders.

Your Profile

  • Bachelor's degree minimum
  • 5 to 10 years experience in the medical device industry.
  • International regulatory experience or certification on medical device
  • Knowledge of European and international medical device directives, regulations and standards.
  • Experience working with international businesses or cultures
  • Knowledge of applicable medical device regulatory requirements worldwide.
  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.
  • Budget management

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -092018-293583