Quality Assurance

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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 and process 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.