Regulatory Specialist

Job Elements: -

• To enable registrations of product and their subsequent sale in international markets and to provide expert direction to staff in matters of Regulatory Affairs.
• Interpret regulatory requirements, identify and obtain the data needed to enable regional regulatory registrations of products.
• Develop the regulatory strategy and approval pathways to enable product registrations.
• Compile and coordinate the submission of regulatory applications to international regulatory agencies to enable product registrations.
• Give guidance to product development teams to aid effective project planning, including timing and relative challenges of regulatory requirements.
• Provide regulatory input to new product development teams in key areas, e.g. labelling, clinical evidence, risk management, safety and sterilisation to enable effective project planning.
• Interpret customer regulatory requests giving direction on their fulfilment.

The ideal candidate will have:

• A Bachelor’s degree or equivalent in a scientific field.
• A minimum of 2 years directly relevant regulatory experience, including the EU & US
• A sound understanding of the key regulatory environments and operation of National Competent Authorities.
• An ability to provide innovative solutions within the constraints of the regulations.
• Excellent verbal and written communication skills.