Global Regulatory Affairs Associate/Senior Associate (medical devices)/Project Manager
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
Global Regulatory Affairs Associate/Senior Associate (medical devices)
We are pleased to offer a great new position in our International Regulatory Affairs team. This is a very nice opportunity to join a successful and growing global consumer health care organisation and be part of a diverse and well respected Regulatory Affairs function. The role is based in Nazareth, Belgium.
MAIN OBJECTIVES OF THE JOB
- To work on global Regulatory Affairs projects supporting business needs in the medical device area including new product developments, roll-outs and maintenance projects.
- To help ensuring compliance with ISO13485, ISO14971 and other harmonized standards
- To help ensuring compliance with EU Medical Device Directive/EU Medical Device Regulation & other related regulatory requirements including relevant ISO standards
MAIN DUTIES AND RESPONSIBILITIES
- Work as part of a multi-functional team by providing regulatory input to new product development, including artwork approvals, label claims and associated supporting documentation
- As part of the team support the process of CE marking of new and existing products
- As part of the team ensure product notifications/certifications/registrations are correct and compliant with the relevant legislation.
- Maintain, review, approve and update of technical files compliance with the MDD 93/42/EEC and IVD 98/79/EC
- Approve Master Artwork and Master Texts from a regulatory perspective
- Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territory
- Initiate corrections to Master Documents & Regulatory Affairs Procedures as required
- Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage impact of these changes
- Analyze regulatory issues and inform relevant stakeholders of developments in national and EU regulations and legislation and provide regulatory intelligence
- Carry out other related regulatory affairs duties as required
- ‘Give it a go’ and positive attitude being keen on creative and problem solving thinking whilst being thorough and focussed with the necessary attention to detail.
- Ability to work on several projects in parallel in a flexible manner both autonomously and in a team environment.
- Good communication skills.
- Passion for regulatory affairs
QUALIFICATIONS AND WORK EXPERIENCE
- Fluent in English
- Master’s degree in Science, Life Sciences, International Law, European Policies or other relevant fields
- At least two years hands-on experience in a consumer product related EU regulatory environment. Experience in EU chemicals, biocides and/or cosmetics legislation is a plus.
We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.