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Job Details

Senior RA Specialist

Company: Thornshaw Recruitment
Location: Offaly, Republic of Ireland
Reference: LCD9114
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Negotiable

Job Summary:

Our client is a leading medical device company. Due to continued growth they have a vacancy for a Senior Regulatory Affairs Specialist.


Our client is a leading medical device company.   Due to continued growth they have a vacancy for a Regulatory Affairs Specialist.

As a Senior Regulatory Affairs Specialist, you will be a key member of their Regulatory Affairs group and required to demonstrate flexibility as priorities change.

Key role of this position is to support department goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company’s range of medical devices. Maintains site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS, IEC 60601, and other International Regulations.


  • Development of and collation of data for EU MDD Class III Design Dossiers for submission to Notified Body, maintains currency of CE Technical Files aligned with device and process changes.
  • Interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirement
  • Support reviews of Change Request Notes for change impact on regulatory filings, and update latter where applicabl
  • Key member of the New Product Introduction, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements.
  • Integral part of the Risk Management team, maintains Risk Management Files (MDHA, D-FMEA, P-FMEA etc) in line with real time PMS data, device and process changes.
  • Maintains, updates and submits change data to UL and CSA for device file updates
  • Assists in preparation of regulatory submissions to FDA 510(k), LAPAC and other International Regulatory agencies.
  • Communicate with Notified Body, Competent Authority, and international regulatory authorities regarding license applications, CoFS updates, and vigilance and compliance issues
  • Performs regulatory review of product labelling, provides P-MAP review of device promotional literature.


  • At least 5-7 year’s experience in an RA role within an FDA and / or ISO 13485 regulated medical device environment.
  • Demonstrable knowledge of 21CFR820, 803 and 807, and ISO 13485 requirements
  • Experience in internal auditing for compliance to Medical Device QSRs an advantage

For full job spec contact Linda at +353 1 2784671 or email your CV to

Apply for this job: Senior RA Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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