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Job Details

Director, Regulatory Affairs- Medical Device

Company: Barrington James Clinical
Reference: CRBG -CROMD
Closing Date: 03 Feb 18
Type: Permanent
Salary (£): Competitive

Job Summary:

For more information, please call Carlos Biggemann on +44(0) 1293 776644



  • Oversee the process of preparing product submissions to domestic and international regulatory bodies and manage the process from inception to approval
  • Interact with FDA, including preparation of PMA/IDE/510K submissions
  • Manage relationship with international regulatory agencies
  • Plan, review, approve required documents from various departments for filing of required information to FDA, including, pre-IND and other consultations with FDA, new IND's, updates to IND's, and original/supplemental NDA filings
  • Provide regulatory review of study protocols, investigator’s brochures, labeling, and integrated summary documents
  • Collaborate with EU regulatory to develop global approval strategies
  • Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements and Maintain up-to-date knowledge of regulatory requirements


  • Bachelor’s Degree in a related field
  • A minimum of 10 years of Regulatory Affairs experience in the device industry
  • Experience working in a small, global company is preferred
  • Strong computer skills, project management skills, and a high attention to detail
  • Strong communication skills (both written and oral).
  • This position may require supervision of junior level staff

Apply for this job: Director, Regulatory Affairs- Medical Device

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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