Director of Regulatory Affairs Medical Devices
Resourcing Life Science Ltd
Germany
vor 9 Tg.

Director of Regulatory Affairs Medical Devices Germany Recruiting for Director of Regulatory Affairs medical devices for our client a leading medical device company with offices globally.

The company designs, develops and manufactures its own products for the global market. Responsibilities : Prepare international and domestic filings / registrations to established timelines and company objectives Represent RA department on assigned projects and provide regulatory guidance as appropriate Coordinate with international contacts on product changes and regulatory notification / approval requirements Regulatory Affair Manager office based Switzerland Prepare reports to meet international regulations and reporting requirements Permanent / Switzerland Review and approve product design control documentation up to Work with Quality and Engineering in generating risk analysis, FMEA, and FTA reports Our client is a leading medical device company with offices globally.

The company designs, develops... More details... Review and approve document change orders and prepare letters-to-file Update departmental procedures as required Clinical Submission Specialist Brussels Ensure applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.

Permanent / Brussels Belgium up to Maintain up-to-date knowledge on international and domestic regulatory requirements Our client is a top 5 global CRO which has enjoyed a number of years of positive growth.

Due to this... More details... Provide support for implementing and maintaining the effectiveness of the quality system Support international product registrations and regulatory approvals Clinical Study Start up Brussels office based Ensuring that subcontractors meet regulatory compliance requirements and are approved by regulatory affairs at the initiation stage.

Permanent / Belgium up to Our client is one of the best CRO on a global level, currently supporting Pharma and Biotech companies.

  • More details... To liaise closely with the Quality Assurance department To liaise closely with the complaint handling team To participate in and support activities associated with Pall objectives Requirements : Good oral and written communication with operational management Extensive knowledge of FDA Medical Device Regulations ( 21 CFR 801, 820 ff) and Guidelines Ability to facilitate and provide leadership when interpreting regulatory standards and guidances Good communication with customers, regulatory authorities and approval bodies in Europe Must be self-
  • motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities Bachelor's Degree in scientific disipline or equivalent.

    One year plus of Management experience, (remote management experience preferred). Minimum 10 years' experience in Regulatory Affairs Experience with US Class II Medical Devices.

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