Senior RA Specialist - Medical Devices - NEW
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Neg
- Start date
- 21 Mar 2023
- Closing date
- 20 Apr 2023
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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 tdunne@thornshaw.com or call Tina at +353 1 2784701/0876811990.
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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