International Regulatory Affairs Senior Associate (Med Device)

工作内容

Perrigo is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Thank you for being part of our mission.Description OverviewWe are excited to be recruiting for an International Regulatory Affairs Senior Associate to be based in either our London, Paris, Rotterdam, or Nazareth (Belgium) location working on our exciting Medical Device Portfolio. The main responsibilities of the role will be to work on a diverse range of Regulatory Affairs projects to meet business needs and ensure Regulatory Compliance of the company’s products with all relevant legislation around Medical Devices, including the MDD, the challenging new MDR, ISO 13485, ISO 14971 and other harmonized standardsScope of the Role

• Work as part of a multi-functional team (Quality, Innovation, Marketing, Supply, etc..) by providing regulatory input to new product development, including artwork approvals, label claims and associated supporting documentation within assigned categories
• Contribute toward strategy, preparation, submission and maintenance of Medical Devices where Perrigo are the Legal Manufacturer in the EU.
• Depending on experience, represent the regulatory department in one or more product categories/ projects as primary point of contact and provide input to management.
• Interpret and implement changes in legislation following Regulatory Intelligence; proactively manage impact of these changes
• Discuss strategy and issues internally and with authorities/third parties as needed.
• As part of the team ensure product registrations where Perrigo are both Legal Manufacturer or Distributor are correct and compliant with the relevant legislation.
• Provide the Quality team support in maintaining the ISO 13485 Quality Management System
• Assist in the process of reporting and investigating critical non-conformities, corrective / preventive actions and look for opportunities for improvement
• Provide input to risk management plans and risk management files in line with ISO 14971
• Maintain, review, approve and update of technical files compliance with the MDD 93/42/EEC and MDR EC/2017/745
• Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territory

Experience Required

• Bachelor or master’s degree in Medical/Life Sciences or other relevant fields
• 2-4 years of experience in a regulatory environment is desired
• 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.