Senior Regulatory Affairs Specialist
Due to continued and exciting expansion my client, are now hiring a Senior RA Specialist. The successful candidate will report directly to the QA/RA Director and will be a key member of the Quality & Regulatory team as the company continues to grow. This is a full-time position based in the company’s Dublin office.
The role involves:
· Provide regulatory guidance to the product development team to develop and implement appropriate regulatory strategy within the product development process including the management and assessment of process/design changes on product regulatory strategy
· Collaborate with the wider team to ensure that necessary and sufficient regulatory activities and documentation including product design and technical files are generated and maintained.
· Lead the development and submission of clinical and regulatory files to relevant regulatory bodies and driving to successful approvals.
· Keep up to date with changes and interpret relevant standards and ensure the company meets applicable regulatory requirements
· Engage with and prepare for interactions with notified bodies and regulatory authorities including audits, inspections, presubmission meetings.
· Engage with the QMS to ensure delivery of the overall quality and regulatory strategy & support the achievement of the business quality and regulatory objectives
Skills / Experience required:
We are looking for an exceptionally organised individual who can self-manage multiple priorities and urgent issues as they arise. The ideal candidate is focused on resolving issues in a proactive and timely way with a hands-on contributor approach.
Essential
· Bachelor’s Degree in Engineering, Science, or related field
· 4 years’ experience in medical device regulatory role
· Recent regulatory experience including FDA regulations, ISO 13485, Medical Device Regulation and other applicable national and international regulations and standards
Desirable
· Master’s degree in Engineering, Science, or related field
· Experience in implantable medical devices
· Experience with regulatory aspects of medical electronics and medical device software
· Experience with clinical investigations of medical devices
Skills
· Strong communication and influencing skills
· Ability to work under pressure and meet deadlines
· Target driven individual who can work to own initiative
· Extensive knowledge of regulatory principles
· Ability to think analytically and problem solve
· Ability to make decisions and own processes
· Thrives in a fast-paced start-up environment
For full details send your CV to [email protected] or call Tina at +353 1 2784701/0876811990.
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
