EAST FLANDERS, Belgium
Our partner is a leading global operating company. They produce innovative products for the consumer market.
As Regulatory Affairs Lead you will ensure Regulatory Compliance of the company’s products with all relevant product related legislation predominantly in the area of Medical Devices in the EU (European Directives and Regulations for Medical Devices, ISO13485, ISO14971 and other international/harmonized standards for Medical Devices). The chosen individual will be expected to support and assist the business in any area of Regulatory Affairs required.
- Lead a team of Regulatory Affairs professionals;
- Report to Senior Management on project progress and regulatory compliance issues for category products which may impact the direction or the financial value of the wider organisation;
- Maintain a high level of Regulatory Affairs expertise within the team (regulatory intelligence, training, networking);
- Work as part of a multi-functional team by providing regulatory input to new product development, including artwork approvals, label claims, advertisement materials and associated supporting documentation;
- Provide regulatory input into new product and brand strategies;
- Analyze complex regulatory issues incl. impact assessments of changes in regulatory requirements, develop implementation strategies and inform relevant stakeholders;
- Involvement and oversight of the day to day running of the categories and provide leadership to;
- Ensure product registrations, certifications and notifications are current and compliant;
- Review and approval of Medical Device Technical Files in compliance with the MDD 93/42/EEC, MDR (EU) 2017/745;
- Participate to central Category and product meetings representing the Regulatory Affairs function;
- Ensure timely and effective communication and collaboration with other departments including safety, quality, innovation, supply and marketing;
- Liaise with affiliates, responding to regulatory queries, and providing notification / registration documents as necessary for the European territory;
- Communicate with competent authorities, notified bodies, local and international regulatory authorities regarding 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.
- Master degree in Scientific or Legal Subject;
- 10 years of relevant experience in Regulatory Affairs, with a practical experience of working with Medical Device legislation in the EU, a background knowledge of all types of Consumer Health/Self-Care products and experience of managing a team of regulatory professionals;
- Fluent in English.