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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-title

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

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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