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Job Details

Regulatory Affair Manager - Medical Device

Company: Barrington James Clinical
Location:
Reference: CRBG - MDRA
Closing Date: 28 Jan 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

For more information please call Carlos Biggemann +44(0)1293776644 or email cbiggemann@barringtonjames.com

Requirements:

Primary Tasks and Responsibilities:

  • Development and execution of regulatory affairs (RA) plans and strategies for new products and foreign countries registration (RA) processes.
  • Compilation and updating of corresponding Product Master Files (PMF) and other filings for registrations worldwide.
  • Support and execution on RA filings (e.g. DIMDI Notifications, Recalls, MDD Vigilance, PSUR reports, Annual Reports).
  • Collaboration on the development of product and process validation and verification plans as well as corresponding support of the development department and development processes including Design Control (12-Step Development Methodology).
  • Support of Quality Management (QM) in general (e.g. maintenance of the ISO 13485 /MDD based quality system) and especially in the area of overlapping tasks (e.g. LPI (labeling, packaging, IFUs), adjustment of QM system on FDA and GMP requirements.
  • Support on Complaint Handling and CAPA System.
  • Support on design, conduction and documentation of preclinical and clinical trials.
  • Execution of Internal Audits.
  • Participation on External Audits: Notified body, customers, legal authorities, FDA.
  • Development of Risk Assessments (RIS) and Risk Management Plans (RMP) according to ISO 14971.
  • Execution of trainings, especially on RA and QM relevant topics.

Skills / Competencies:

  • Good knowledge about Medical Device Directive as well as general regulatory standards and regulatory guidelines.
  • ISO 13485, ISO 14971 and ISO 10993-ff experiences.
  • Experience in the field of class III and/or drug device combination products.
  • Experience in class III CE applications and key international players (USA’s 510(k), PMA, Canada) as well as experience in registrations in Asian countries (especially China) are advantageous.
  • Well organized and good spelling style.
  • Regulatory experience in preclinical and clinical studies.
  • Skills in product and process qualifications, verifications and validations.
  • Experience with invasive catheters and implants are advantageous, as well as experiences in biodegradable implants.
  • Project planning and execution

Experience & Educational background required:

  • Experiences in Quality Management and / or Regulatory Affairs in the field of medical devices for at least 3 years are mandatory
  • Medical Technology Engineer or equivalent with masters degree preferred with a focus on and special skills, respectively, in Regulatory Affairs and Quality Management

Apply for this job: Regulatory Affair Manager - 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

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