TEC Partners are working with an exciting medical device company who are looking to expand their regulatory affairs team with the appointment of an experienced Senior Regulatory Specialist. You will directly support the registration and licensing in the US, Canada and EU and indirectly support the international market groups for all licensing. A broad scope of analysis of regulatory operations will need to be provided for problem solving involving regulatory data and the evaluation of identifiable factors.
Senior Regulatory Affairs Specialist Responsibilities:
* Plan, generate, and coordinate worldwide regulatory submissions for product/solution licensing, and maintenance of existing regulatory licenses, including change submissions and associated submission testing activities
* Independently manage multiple projects, department initiatives, and day-to-day tasks
* Support the Regulatory team with other regulatory-focused activities as required
* Review the impact of changes to standards and regulations, assisting with any required conformance and engineering change activities
* Responsible for implementing global regulatory strategy and roadmaps through understanding the competitive market landscape and product marketing strategy
* Provide senior regulatory support to product development teams throughout the design control process, including the analysis of applicable standards, guidance on risk assessment and effective implementation of the regulatory plans
Senior Regulatory Affairs Specialist Requirements:
* Bachelor’s degree (or equivalent) with a broad scope of worldwide medical device registrations
* A minimum of 5 years in a medical device company with higher risk devices in EU Class IIb and their equivalent classifications in other regulatory systems, experience of EU Class III is desirable
* Experience with successful preparation and submission of US Class II 510(k) or US Class III PMA is desirable
* Strong background in Design Controls
* Working knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, other global laws and regulations
* Experience in electro-medical devices (IEC 60601 series) and medical device software (IEC 62304, IEC 82304) is highly desirable
Being an integral part of this ever growing, successful medical device company, you are rewarded with private health care, competitive salary and learning development opportunities.
If this exciting opportunity working for a global company sounds of interest, please apply immediately with an up to date CV.