Senior Regulatory Affairs Specialist


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

10th November 2021

Location

Galway

Salary/Rate

£49698 - £50602

Type

Permanent

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

I am working closely with an innovative medical device start-up in Galway who are one of Europe's leading developers in the field of neurovascular medical devices. There's never been a better time to join the team, with manufacturing ramping up due growth. Located in the heart of Galway's medtech hub, the company have moved to a new facility to accommodate the increase in headcount and product development. They truly care about their patients and are looking for a dedicated Senior Regulatory Affairs Specialist to join them. What Will I be doing as a Senior Regulatory Affairs Specialist ?Maintain an excellent understanding of global medical device regulations, for specific jurisdictions, primarily in accordance with specific FDA guidance & MDD 93/42/EEC.Develop global regulatory strategies for the company in collaboration with regulatory affairs management.Plans and prepares regulatory submissions with specific emphasis on US FDA, i.e. 510(k), HDE, IDE and PMA submissions.Communicates directly with regulatory authorities to ensure product approvals are achieved in a timely manner.Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.Provides ongoing support to currently marketed products as necessary including input on change notifications, etc.Ensures a thorough understanding of the products they are assigned.Can act as a designee for the RA management, if required.Lead the Design Review process in compliance to internal procedures including EU and FDA requirements.Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records. What I need to be a Senior Regulatory Affairs Specialist ?Minimum 5 years' experience in Regulatory Affairs, Design Assurance or similar role in a medical device company.Primary and/or a postgraduate degree BS, MS, or PhD (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field).Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.Working knowledge of FDA requirements including Quality System Regulation (21 CFR 820), the Medical Device Directive (93/42/EEC) and applicable harmonised standards and the ability to apply them in practice.Previous experience with submissions to US FDA is a distinct advantage If you'd like to discuss the chance of becoming Senior Regulatory Affairs Specialist, please send across your current CV and we can have a confidential conversation about this opportunity. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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