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Medical Devices Regulatory and Policy Assessor

Reference:A006033
Location: Dublin
Qualification:Degree
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Regulatory Affairs, Medical Advisor

The Medical Devices Regulatory and Policy Assessor will work as part of the Communication & Policy Team within the Regulatory and Policy section of the Medical Devices department. The Regulatory and Policy Assessor will contribute to the planning, coordination, development and implementation of the legislative requirements for medical devices and in vitro diagnostic medical devices at national and European levels. The Regulatory and Policy Assessor will help inform policy and development decisions and, if required support the planning and development of medical device activities within this company.

The section’s overall objective is to help ensure:
- The company’s medical device activities are appropriate, prioritised and relevant to the stakeholders that we serve
- The company is consistent and clear in its policy and regulatory approach to medical devices and in-vitro diagnostics
- The company communicates effectively, both internally and externally on medical devices and in-vitro diagnostic issues and provides relevant information on devices and on our activities
- Departmental activities are completed with administrative, clinical, legal, regulatory, technical and scientific excellence.

Strategic Objectives
o Supporting the Communications and Policy lead in the management and the ongoing development of the section and Medical Devices department to ensure our regulatory activities are centred on scientific & regulatory excellence, are value-driven and optimised to achieve the highest standards of device safety, performance and care for patients and healthcare systems.
o Working with the Communications and Policy lead to prioritise work objectives and to ensure that the strategic goals and targets of the Medical Devices department are achieved.
o Contribute to the development of legislation and policy relating to medical devices at European and national level.
o Assist in the planning, coordination and development of the communication strategy on implementation of new EU legislation on medical devices.
o Contribute to the development and management of a training strategy for medical devices within this company.
o Working with the manager and device colleagues in building strategic alliances and fostering relationships with relevant stakeholders, EU and international regulatory authorities.

Operational Objectives
o Assist their Manager and Section Manager in meeting the objectives, goals and targets of the section and the Medical Devices department.
o Contributing to the company processes to ensure activities and follow up actions are conducted in accordance with appropriate legislation and administrative procedure.
o Promote optimisation of assessment activities to ensure they are proportionate, appropriate, targeted and effectively prioritised (risk based approach).
o Submitting reports as required and maintaining appropriate records of meetings and activities.
o Assisting in the compilation of data and preparation of management reports as required.
o Contributing to Regulatory and Policy section team meetings, as appropriate.

Technical Objectives
o Regulatory development & Management
o Participate in the coordination, communication and implementation of legislation and policy relating to medical devices and on in-vitro diagnostics.
o Input to the company’s contribution to EU and international regulatory activities and meetings to ensure they are effective, impactful, consistent and clearly communicated.

QUALIFICATIONS AND EXPERIENCE
- To be considered for this post, candidates must have the following skills and experience:
o 3rd level degree in legal studies or a relevant discipline (e.g. life sciences or healthcare)
o Minimum of three years’ experience working in a communication and policy environment relating to health products, preferably related to medical devices
o Knowledge of regulatory systems and relevant European and National legislation (current and future) relating to medical devices
o Excellent communication skills, with the proven ability to deliver appropriate information to the right people, using a range of written, verbal and presentation skills
o Experience of regular high-level representation of organisational/national positions at national or European level
o Excellent decision making skills with a proven ability to deliver in a capacity utilising these skills
o Be highly motivated with the ability to manage deadlines in a changing regulatory and organisational environment
o Have excellent administrative, computer and organisational skills
o Demonstrate initiative and team working capabilities


If you would like further Information you can contact the recruiter directly:

Libby Ryan | Tel: +353 (0) 1 507 9254




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