Regulatory Affairs Manager

Working for an SME Medical Device manufacturer, you will be responsible for the delivery of the company's development regulatory roadmap. This will be achieved through leading the regulatory elements of the company's product development efforts and compliance programme as well as supporting its customers' regulatory requirements and projects.

Key competence / skills / abilities:

1. Regulatory, science or engineering degree or equivalent.
2. Knowledge of the Medical Device Directives Regulation EU 2017/745/EEC, 21 CFR 820, UKCA.
3. Ability to gather, analyse and interpret regulatory information and changes in the regulatory landscape, taking ownership for delivery.
4. Pragmatic team member and flexibility to work within the dynamics of a cross-functional team.
5. Great communication skills.

Desirable Additional Experience:

1. Experience of managing people in a similar role, with the ability to lead, influence, and motivate a team.
2. Networking abilities with internal and external stakeholders (competent authorities and registration bodies).
3. Strategic and analytical thinking.
4. Highly structured way of working.
5. Comprehensive knowledge of processes and regulations in medical device and drug development; combination product (device-device), drug Masterfile compilation experience is highly desired.
6. Strong communication skills, goal- and solution orientation, flexibility, and assertiveness.
7. Medical device or pharmaceutical product manufacturer experience.
8. Experience of developing regulatory strategies for new product development and design changes.
9. Demonstrable experience of technical files, design dossier and drug master file creation.