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  • Location

    Brussels, Belgium

  • Job title:

    Global RA Lead Consumer Healthcare

  • Sector:

  • Job ref:

    44271

  • Startdate:

    2020-06-09

The Company
Our partner is a leading global operating company. They produce innovative products for the consumer market.
Role Description

This position will provide strategic support to the company, lead a team of regulatory professionals and report to senior management. It is the responsibility of this role to ensure that the company's products comply with all relevant product-related legislation, mainly in the field of medical devices in the EU (European Medical Device Directives and Regulations, ISO13485, ISO14971 and other international / harmonised standards for medical equipment). The chosen person is expected to support and assist the company in any area of ??required regulation.
 

Responsibilities

  • Leading a team of regulatory professionals
  • Report to senior management on project progress and regulatory issues for category products that may impact the direction or financial value of the wider organisation
  • Maintain a high level of regulatory expertise within the team (regulatory information, training, networking)
  • Work as part of a multi functional team by providing regulatory input for new product development, including artwork approvals, label claims, ads and associated supporting documentation
  • Provide regulatory input for new product and brand strategies
  • Analyse complex regulatory issues, including impact assessments of changes in regulatory requirements, develop implementation strategies and inform relevant stakeholders.
  • Involvement in and supervision of the day-to-day management of the categories and management;
    • Ensure that product registrations, certifications and notifications are current and compliant
    • Review and approval of technical files of medical devices in accordance with MDD 93/42 / EEC, MDR (EU) 2017/745
    • Participate in central category and product meetings that represent the Regulatory Affairs function
    • Ensure timely and effective communication and collaboration with other departments, including safety, quality, innovation, delivery and marketing
    • Liaise with affiliates, respond to regulatory inquiries and provide notification / registration documents for the European territory as necessary
    • Communicate with licensing, notified bodies, local and international regulatory authorities about license applications and compliance issues
  • Contribution to development of category budget and Functional OGSM
  • Collect data and write reports for projects / assignments as indicated by the Regulatory Affairs Director


Requirements

  • Master in a scientific or legal subject
  • Fluent in English
  • 10 years of relevant regulatory experience, with hands-on experience working with EU medical device legislation, background knowledge of all types of consumer health / over-the-counter products and experience in leading a team of regulatory professionals.
  • Enthusiastic with the ability to communicate that enthusiasm to others
  • Ability to handle pressure and work effectively in high pressure situations
  • Flexible, agent of change
  • The ability to work both autonomously and in teams
  • Ability to prioritise decisions and activities to ensure resource efficiency and address critical issues affecting the business
  • Excellent project management and organisational skills
  • Excellent communicator
  • Excellent problem solving skills.
  • Passion for health products and compliance with regulations
  • Strong entrepreneurial spirit, innovative and creative

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