Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Director, Regulatory Affairs- Medical Device

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

Job Summary:

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

Requirements:

DESCRIPTION OF JOB DUTIES

  • 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

QUALIFICATIONS/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
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.