My client is a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- 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 requirements
- Support reviews of Change Request Notes for change impact on regulatory filings, and update latter where applicable
- 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, supports maintenance of Risk Management Files (MDHA, D-FMEA, P-FMEA etc) in line with real time PMS data, device and process changes.
- Supports communication between the engineering department and third party electrical safety certifiers
- 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 PMAP review of device promotional literature.
- Perform vigilance reporting and other Agency complaint trending for devices, and develop necessary solutions to mitigate against repeats, and improve process.
- Reads related regulatory publications and documents to stay informed about current regulatory actions that may impact owned devices.
- Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
- Support assessment and closure of audit findings or other actions related to regulatory / QMS audits as needed.
- Assist QA in CAPA investigation and root cause analysis, and performance of effectiveness activities.
- Support development of regulatory strategy for and execution of transition from the Medical Device Directive to the Medical Device Regulation.
- Performs other duties as required.
- Third level qualification in an engineering or science discipline.
- At least 5+ years’ experience in a RA role, or equivalent medical device industry role (i.e. quality, engineering, etc.) within a CE marking, FDA and ISO 13485 regulated medical device environment.
- Demonstrable knowledge of EU Medical Device Directive, 21CFR820, 803 and 807, and ISO 13485 requirements
- Experience in internal auditing for compliance to Medical Device QSRs is not required, but is an advantage
- Good planning and organizational abilities.
- Must have the ability to communicate effectively with management and fellow peers, both in person and remotely (electronically/via phone).
- Pro-active with proven ability to work under own initiative, and strong team player.
- Wiliness to travel to other sites as part of duties
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