Quality Assurance
4 giorni fa
Join our Team We are currently looking for a Quality Assurance & Regulatory Affairs Specialist (M/F/d).
He/she will provide guidance and execute regulatory plans and strategies, working with the project core team. He/she will also be accountable for the implementation of the premarket regulatory procedures and the compilation of regulatory clearance documentation to achieve timely regulatory clearances.
Main Tasks:
Provides quality assurance of design (Design Authority)
Participates as a mandatory core team member on premarket Product Development teams to assure regulatory and process conformance for new and maintenance projects
Guides Product Managers and Project Managers regarding compliance issues and ensure that decisions are properly documented and is following its processes
Ensures that Product Quality Strategy is completed compliantly and thoroughly
Creates and maintains the key regulatory deliverables
Manages the creation and maintenance of the risk management file
Verify that all risk mitigations are implemented in the course of the project
Conducts and document quality planning for new products
Reviews product documentation (e.g. design history file) to ensure compliance with regulations
Makes recommendation on product release to QARA management
Provides compliant design control files and defend pre market activities during external regulatory inspections
Identifies ongoing training needs of the team and provide training as required
Takes actions if there are process issues for related premarket/design control processes
Ensures that the NC/CAPA process is followed as required and take actions if there are product or project issues
Provides KPI data for internal reporting on project status and regulatory submissions as QMR and scorecard input for pre-market activities
Performs project reviews/audits of Design History Files and Device Master Records as required
Reviews and audit related NCs and CAPAs
Reviews and audit product labelling
Audits key suppliers during the design phase
Validates design andprocess for the products as software medical device
Lead the lifecycle, maintenance, and remediation activities of legacy products
Reviews all test procedure results
Maintains all controlled document files and test records in a timely and accurate manner.
**Required Skills**:
University STEM Degree with preference accorded to Biomedical and Computer Engineering
At least 2 years of experience in a regulated industry preferably medical device, pharmaceutical or related holding a position in quality management, quality assurance and regulatory affair position or project management in medical device development
Knowledge of Design control regulations and requirements
Previous experience with Medical device classification rules and regulations
Ability to carry on Medical device regulatory submission regulations and requirements
Knowledge of Clinical risk management regulations and requirements
Previous experience with software development methodologies and practices
Knowledge of CAPA/NC regulations and requirements
Confident with Privacy and security regulations and requirements (GDPR)
Knowledge of usability, safety and product related standards
Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive and Medical Device Regulation MDR and IVDR.
Knowledge of software development methodologies and practices
QMS tools (CAPA, regulatory clearances, KPIs)
Awareness of Medical Device product safety and Security Standards including ISO 27001 and GDPR
Sound command of English
Other important required skills:
Excellent organizational skills and attention to detail
Self-motivated and able to grasp new concepts and learn quickly
Ability to stay organized between changing priorities and multiple simultaneous projects
Able to motivate others and facilitate a positive work environment
Strong attitude in managing projects and deliverables with a high level of accuracy and completeness.
Ability to solve problems while exercising sound judgment and timely decision-making skills
Must be able to communicate technical information to development teams in a supportive and meaningful manner
Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
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