Risk Management & Clinical Manager

Position Overview

Responsible for reviewing and documenting medical device risks to ensure adequate documentation and processes are in place for compliance with global regulatory frameworks. This role is responsible for working with regulatory affairs, engineering, quality, clinical and other organizations to ensure timely and effective execution of the GCE Risk Management Procedure and related areas. Applicants must be self-motivated, and attentive to detail in a highly regulated environment.

Duties & Responsibilities

These responsibilities include:

• Design and execution of risk management documentation according to ISO 14971 and established company procedures and templates, such as Identification of Hazards, Risk Analysis, Risk Estimation, Mitigation and Effectiveness, Risk Management Plans and Reports, FMEA and other relevant documents.
• Experience in Article 61(10) Essential
• Inputs and Management of 62366
• Provide input to Quality Complaints from a Risk perspective
• Familiarity with ISO 13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents and certain individual product technical standards.
• Responsible for continuous maintenance of above documents for all product groups as well as new products/configurations.
• Timely completion of required documentation for Notified Body submission projects according to tight project deadlines and flexible priorities.
• Collaboration with regulatory, quality, engineering and clinical functions.
• Participation in Corrective and Preventive Actions arising from audits, Notified Body reviews and other nonconformances.
• Incorporation of new information arising from revisions to technical standards, regulatory requirements and guidance, hazards identified during post-market surveillance and product evolution.
• Competence with various specialist softwares including Quality Management, Document Management, Incident Reporting and Project Management tools.
• Active participation in continuous improvement of risk management and related processes including designing and applying new or revised procedures and templates in a timely and accurate manner.
• Immediate escalation of threats to compliance via the correct channels.
• Occasional participation in internal and external audits if required.
• Constant compliance with all company legal, personnel, environmental and data protection policies, among others.

Qualifications

Language Capabilities

• English (professionally fluent)

Education Requirements

Minimum Degree in life Sciences / Engineering

Experience Requirements

• Minimum of 8 years working in risk management / engineering / technical documentation in medical device manufacturing or equivalent highly-regulated manufacturing field e.g. pharmaceuticals, aerospace, oil & gas serving EU and/or US markets
• Demonstrable experience in generating and submitting documentation required in gaining Global Technical Approvals for companies in above industries
• Experience in working collaboratively within a group investigating Complaints
• Management of responses of Complaints
• FMEA / dFMEA inputs and upkeep
• Working with multidisciplinary teams across the organization, national approvals organizations and third-party contractors

Desirable Technical Requirements

• Strong understanding of Medical Device Risk Management, including ISO 14971, FMEA or similar methodologies
• Strong knowledge of Medical Device Post Market processes, including Complaint Handling, CAPA, Risk Assessment and Field Action
• ISO13485, ISO14155, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents
• Strong oral and written communication skills.
• Demonstrated ability to work independently with limited supervision and take accountability for own workload.
• Experience working on specialist organizational IT programs.