International Regulatory Affairs Associate/Senior Associate

Job content

Description

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.

We are excited to be recruiting an International Regulatory Affairs Associate/Senior Associate dependent on experience to be based in our Nazareth, Belgium location. At Associate level, we are happy to consider graduates and individuals at the cusp of their RA career!The main responsibilities of the role will be to work on Regulatory Affairs projects as required to meet business needs and ensure Regulatory Compliance of the company’s products with all relevant legislation around Medical Devices, including ISO13485, ISO14971 and other harmonized standards, IVD and MD directives, MDR & other regulatory requirements.

Main Duties & 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. Contribute toward strategy, preparation and submission of new regulatory filings
• Depending on experience, represent the regulatory department in one or more product categories as primary point of contact and provide input to management.
• Support and drive the process of CE marking of new and existing products.
• Discuss strategy and issues internally and with authorities/third parties as needed.
• Analyse regulatory issues and inform relevant stakeholders of developments in national and EU regulations and legislation and support with regulatory intelligence
• As part of the team ensure product 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
• Provide support in maintaining the ISO13485 Quality Management System
• Assist in the process of reporting and investigating critical nonconformities and opportunities for improvement
• Support on report and follow-up of corrective / preventive actions if necessary
• Provide input to risk management plans and risk management files in line with ISO14971
• Provide input for analysis of data and/or management review, if required
• Carry out other related regulatory affairs duties as required
  

Requirements

• Bachelor or Master’s degree in Medical/Life Sciences or other relevant fields
• 2-4 years of experience in a regulatory environment is desired for the Senior Associate role, but we are happy to consider graduates with the right motivation for the Associate level
• Self-motivated, flexible and open to changing requirements
• Highly driven with enthusiasm to meet requirements and cope under demanding pressure
• The ability to work autonomously and in team
• The ability to lead and support several concurrent projects/products
• The ability to priorities decisions and activities to ensure efficient use of resources and address critical issues impacting the business
• Excellent project management and administrative skills
• Passion for products and regulatory compliance management
• Being thorough and focused
• A strong entrepreneurial spirit, managing RA as a tool to support the business.
• Being keen on innovation and creative thinking and problem solving
• Excellent communicator in English. Additional language skills are preferred
  

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.