REGULATORY ENGINEER- Medical Devices
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Negotiable
- Start date
- 17 Jun 2019
- Closing date
- 9 Jul 2019
View more
- Discipline
- Regulatory Affairs, Compliance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Regulatory Engineer for Global Medical Device Company. On behalf of my client, we are currently seeking applications. This permanent position will be responsible for, maintaining quality standards and ensuring regulatory requirements are met with regard to their products.
ESSENTIAL JOB FUNCTIONS:
Regulatory Affairs Responsibilities:
- Generate and maintain technical files for CE Marked Products and all other relevant documentation required to comply with the Medical Device Directive 93/42/EEC and its relevant national transpositions and any other national or international regulations which apply to company.
- FMEA execution and Risk management reports as per ISO 14971 as part of technical file updates.
- To correspond / communicate with auditing bodies and regulatory authorities in all relevant matters relating to company.
- To promptly reply to customer and regulatory queries in relation to quality, technical and regulatory information for products manufactured & distributed.
- To liaise with the relevant markets and update product registrations.
- Create and maintain Own Brand Labelling Files.
- The person responsible for regulatory compliance shall at least be responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
Key requirements:
Third level qualification, degree or other formal qualification in medicine, pharmacy, engineering or another relevant scientific discipline.
A minimum of 2 years professional experience in regulatory affairs or in quality management systems relating to medical devices.
Knowledge and experience in regulatory affairs / quality compliance, quality assurance within a medical device company or Pharmaceutical field.
For full details contact Tina at +353 1 2784671 or email your CV in confidence to tdunne@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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