Regulatory Affairs Manager

1. Coordinate and prepare regulatory submissions
2. Prepare and follow up product registration files
3. Develop and maintain regulatory knowledge of European and US regulations
4. Manage the final product submissions and negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
5. Guide and influence technical groups in areas of product development, labelling and promotion
6. Assess impact of new regulation and implement appropriate changes
7. Provide project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
8. Monitor applicable regulatory requirements; assure compliance with Client's and external standards
9. Perform gap analysis and propose solutions
10. Develop and document sound regulatory decisions and justifications
11. Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
12. Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Client values.
13. Carry out other reasonable tasks as required by the Line Manager.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Principal Relationships

Other regulatory managers, project teams

Education and Experience required

Minimum BSc in science subject

Knowledge of CE mark process; technical file construction, Essential Requirements, Risk management

Knowledge of US 510k process

Substantial experience of working in a medical device business in a regulatory role

Skills and Attributes required

Creative, accurate, problem solver, high ethical standards