Join a growing Medical Device start-up company as a Clinical Affairs Specialist.
Key Responsibilities
* Prepare clinical documents for submission to Ethics Committees, Institutional Review Boards and regulatory authorities such as the FDA and Competent Authorities.
* Liaise with external vendors like CROs, core labs, and biostatisticians.
* Collaborate with study coordinators and investigational site personnel to coordinate clinical trial activities.
* Assist with tracking patient enrolment and data management.
* Support regulatory activities related to clinicals.
* Ensure clinical data is correctly documented and analysed.
* Adhere to SOPs, Good Clinical Practice regulations, and other relevant regulatory requirements.
Requirements
* Degree in Engineering or Science discipline.
* Minimum of 2 years' experience in the medical device or pharmaceutical industry.
* Understanding of clinical trial requirements and Good Clinical Practice.
* Regulatory experience is an advantage.
* Excellent interpersonal & communication skills essential.
* Excellent writing skills and comprehension skills.
* Experience working in an SME environment desirable, preferably in a medtech start-up.
* Commit to ongoing personal development to improve technical and non-technical skillsets.
* Experience in preparation of clinical trial documentation desirable.
* A hands-on mindset.
About Us
Wallace Myers International Recruitment Agency specialises in sourcing professionals for key industries and services. See our website for more details on how we can help you find your next opportunity.