Regulatory Affairs Executive

Job details

Regulatory Affairs Executive: A fantastic opportunity now exists for a Regulatory Affairs Executive to join this leading medical devices organisation. The Regulatory Affairs Executive will take an important role within the organisation and contribute to ensuring the company is fully compliant with all relevant regulations and directives.

Regulatory Affairs Executive - key responsibilities:

• Maintain and update technical files and design dossiers for assigned products within the company's portfolio
• Act as the main Regulatory Affairs point of contact for a specified country or group of countries to ensure medical devices products meet any local regulatory requirements
• Vigilance reporting
• Liaise with Project Development teams to ensure regional regulatory affairs requirements are included within the project plan and prepare pre-marketing documentation
• Provide technical information for tender applications
• Potential for business related travel within the EMEA

Regulatory Affairs Executive - qualifications, skills and experience:

• Candidates will boast a solid academic background, ideally including a degree qualification in Life Sciences or a related discipline
• Comprehensive experience in a regulatory affairs capacity
• A firm and thorough knowledge of Medical Devices Directive 93/42/EEC
• Exceptional organisational, interpersonal and communication skills
• Ability to negotiate / influence effectively
• Knowledge of FDA regulations, ISO13485 and ISO 14971 would be an advantage

Regulatory Affairs Executive: A superb career opportunity for an ambitious individual looking to work for a quality medical devices organisation.