Drive regulatory strategy and registration across global markets for a defined group of ConvaTec products
Drive regulatory processes and activities (such as change control, review of labeling, review of marketing materials, etc)
Develop strong working relationships with internal and external customers
Manage global and regional regulatory projects, including regulatory aspects of new product development
Preparation and submission of regulatory dossiers (US FDA 510(k) submissions; EU CE Marking and UKCA Technical Documentation)
Interface with authorities during the review process
Advise on strategies and registration requirements for product development and marketed products
Lead regulatory assessment and actions for changes to product and QMS processes
Ensure regulatory compliance to maintain market approvals
Provide regulatory support to inquiries from customers and authorities
Provide guidance to business partners and junior staff regarding regulatory requirements

2+ years relevant experience, preferably in a Regulatory Affairs role in the life science industry
Experience dealing directly with Notified Bodies, Competent Authorities, and/or US FDA
Hands on experience of creating documentation compliant with FDA CFR 820 and EU Medical Devices Regulation EU MDR 2017/745 required
Experience of 510(k) submissions desirable
Preparation and submission of EU technical documentation
Experience of regulatory requirements for medical devices containing animal derived materials
Knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971
Demonstrate excellent communication skills
Demonstrate strong organizational skills, including the ability to prioritize workload
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial

Senior Regulatory Affairs Specialist – 12 Month Contract

Key skills