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Details
Senior Regulatroy Affairs Specialsit
Reference: | JCAO0926 | Location: |
Galway |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Regulatory Affairs, Senior Regulatory Affairs Officer
Senior Regulatory Specialist
Our client a well funded high potential medical device start up are currently seeking experienced regulatory professional top join their team. The Senior Regulatory Affairs Specialist will work closely with a cross-functional team to obtain the regulatory approvals/clearances needed to support clinical and commercial use of an innovative new therapy.
Role/Responsibilities
- Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support the needs of the business.
- Develop regulatory submissions to ensure timely product clearance/approval and lead preparation, review and submission of high-quality responses to questions from regulatory agencies.
- Collaborate with the development team to ensure that the data is created using best scientific principles and that submission goals are met.
- Develop and manage product design and technical documentation in compliance with the relevant regulations and standards, ensuring that data is controlled and is appropriately protected from corruption, misuse or damage.
- Assure compliance to applicable laws and regulations of all applicable Health Authorities related to obtaining product approval and maintaining product marketing rights.
- Monitor emerging legislation and guidance in appropriate jurisdictions and contribute to ensuring company-level awareness and compliance where appropriate.
Skills/Experience:
- A Bachelor’s or Master’s degree in a scientific or engineering discipline.
- At least 7 years’ experience in Quality Assurance or Regulatory Affairs for medical device companies, with a track record of success with IDE, FDA 510(k) and PMA submissions.
- Strong experience preparing and reviewing regulatory submissions to achieve timely approval.
- Collaborative team player with solid knowledge of the medical device design and development process.
- Excellent written, interpersonal communication and presentation skills.
- High level of organization with the ability to manage multiple projects.
- Able to apply excellent analytical and computer skills in conducting research, analysing data and writing technical documents -
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322
Quality Engineering Allied Healthcare Project Manager Pharma Sales Manufacturing Executive Biopharmaceutical Scientist Chemistry Packaging Engineer Academic Medical Affairs IT Dublin Laboratory Scientist Academic Product Development Engineer Biotechnology Cork City Limerick PhD Connected Health Quality Assurance Diagnostics Quality Control Sales and Marketing Engineering Supply Chain Medical Device Scientific Pharmaceutical Supply Chain Clinical Research Microbiology Sales and Marketing Life Science Mayo Cork Validation Engineer
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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