Regulatory Affairs Manager (ID 155)

Introductie

For one of our clients, a medical device company, we are urgently looking for a Regulatory Affairs Manager. 

Organisatie

In this role ofRegulatory Affairs Manageryou need to ensure that the company meets the obligations of the authorized representative described in the Medical Device Directive (MDD) and the importer, distributor and authorized representative obligations described in the Medical Device Regulation (MDR) excluding the activities linked to vigilance and Post Market Surveillance. In addition, the function holder monitors the client’s environmental compliance and is responsible for the national registrations of medical devices.

Functie

National Registrations (25% time spent)

Distributes the registration activities between the Sr. RAQA Officer and Registration officer

Contributes to internal activities and projects (e.g. new supplier selection) and collects technical advice/information from the assigned Officer

Ensures the local registration requirements and timelines are tracked and documented

Ensures the registration projects are assigned and executed within timelines and in accordance with the procedures and work instructions

Reports high-level registration status to the RAQA Director

Coordinates projects that impact local market access

Ensure updates in the company’s activities (distributor, importer, exporter and authorized representative) are reported to the Belgian Competent Authorities in due time

Ensures support in tenders related to regulatory topics

Manages, guides and coaches the Sr. RAQA and Registration officer.


Environmental compliance (15% time spent)

Maintains a high-level understanding of new and existing environmental regulations (Substances of Very High Concern in SCIP, hazardous substances, eco-design, circular economy, waste) that may impact the organization’s products and processes

Ensures processes are developed to ensure compliance with environmental requirements (REACH, CLP, WEEE, ,…) for the distribution and import of medical devices and biocides

Ensures maintenance of data and files for future reference, particularly in the event of an audit by a regulatory agency or the client’s Corporation

Ensures customers/distributors to have a point of contact for their environmental related requests

Escalation of non-compliances to the RAQA Director


MDD/MDR (60% time spent)

Ensures the registration of products with the Belgian Competent Authorities to meet the authorized representative obligations in the Medical Device Directive/Regulation

Ensures the maintenance of the certificate library which contains the EC certificates, Declarations of Conformity and the ISO 13485 certificates

Coordinate Risk Management activities on the procedures

Supervises the PVNC/VNC procedure

Provides non-product related regulatory support to internal and external stakeholders

Escalation of non-compliances to the Person Responsible for Regulatory Compliance

Luc Decat
Type of contract Permanent
Sector Medische apparatuur
Country Belgium
Job family Regulatory