Regulatory Affairs Officer

The Role Reporting directly to the Quality and Regulatory Affairs Manager, you will be accountable for preparing submissions for new licences. You will be experienced in applying for registrations worldwide along with exceptional knowledge regarding international legislation. You will be responsible for:
 Applying for worldwide registrations
 Preparing submissions for new licenses including 510k’s, license variations and renewals.
 Monitoring and setting time frames for submissions for all new license applications.
 Keeping up to date with international legislation, guidelines and customer practices in all countries that the company exports to.
 Responsible for compiling and maintain regulatory documentation databases and systems.
 Accountable for the preparation of responses to customers’ requests for information such as written regulatory affairs statements or questionnaires.
 Lead the regulatory development activities for the company’s global products.
 Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labelling changes
 Responding to additional requests from regulatory bodies
 Providing internal support and guidance to the business by meeting internal / external requirements.
 Manipulate data to country levels
 Manage regulatory enquiries on products in a timely manor.
 Monitor and advise on changes to legislation and suggest appropriate actions.
 Ensure a robust system is in place.
 Liaising with relevant departments to ensure regulatory requirements for submissions are met.
 Plan, prepare and compile high quality documentation for registrations.
Skills and Experience The below skills and experience is a requirement of this role;
 Experience in applying for registrations worldwide.
 A clear understanding and practical knowledge of preparing submissions for new licenses.
 Confidence in compiling and maintaining regulatory documentation databases or systems.
 A clear and confident communicator.
 Excellent proven written skills.
 Experience of leading regulatory development activities.
 Knowledge of all applicable standards, regulations and guidance to support pre- and post-market requirements