Regulatory Affairs Specialist

3 settimane fa

Milano, Lombardia, Italia CooperCompanies A tempo pieno

About CooperVision


CooperVision is one of the world's leading manufacturers of soft contact lenses with a presence in over 100 countries.


As a Senior Regulatory Affairs Specialist at CooperVision, you will provide expert support and guidance to products from concept to launch.


You will follow the company’s regulatory strategy for assigned corporate projects, assisting in creating, developing, and implementing global regulatory affairs procedures for marketed products.


Key responsibilities include:



  • Registration Activities
  • Prepares, compiles, and submits regulatory documents for the registration of current and new products in assigned markets.
  • Maintains submission documents, and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
  • Monitors pending submissions to ensure timely approvals.
  • Communicates to management any identified delays that may impact business expectations.
  • Monitors approved registrations in respect to expiry and ensures management is aware of action required to renew in a timely manner to ensure no disruption in product distribution.


  • Monitoring Registration Requirements within Region
  • Works with in-country representatives, contractors or perform independent research to determine regulatory requirements for product registrations in responsible regions.
  • Maintains up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing CooperVision products in a specified region.
  • Communicates applicable regulatory requirements to CooperVision Regulatory Affairs management and business partners.
  • Analyses impact and communicates to management changes in regulations or requirements that have been identified.


  • Compilation of Technical Documentation
  • Authors STED and GSPR documents and compiles Notified Body submissions in line with CooperVision Technical documentation procedures for MDD and or MDR.
  • Supports RA Management with Notified Body requests for information.

About You


We are looking for someone with a strong understanding of ISO 13485 requirements and EU medical device regulations.


Experience & Education


Required:



  • Bachelor's degree in a scientific or technical discipline and working knowledge of medical device regulations.
  • 3-6 years of medical device regulatory experience.
  • Technical writing experience.
  • Medical device industry experience including strong working knowledge and experience with MDD and MDR.
  • Understanding of ISO 13485 requirements and EU medical device regulations.
  • Ability to read and understand technical material.
  • Experienced at reviewing and approving product labelling.

What we offer


You’ll receive competitive compensation and a fantastic benefits package including private medical insurance, 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more.


We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential.


We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision.


About CooperVision


CooperVision is a diverse and progressive global business that appreciates how important fostering a diverse and inclusive culture is.


We offer opportunities for employees to learn and grow within an inclusive and safe space.


Join our team and be part of a company that is passionate about making a difference in people's lives.

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