QAra Specialist

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We are currently looking for a local Quality Assurance & Regulatory Affairs Specialist.

Reporting to the QARA Manager, the QARA Specialist will ensure, in partnership with business partners, the safety, efficacy and quality of products, medical devices and services offered by Dobco.

You will provide guidance and execute regulatory plans and strategies and working as a liaison between the Global QARA team and the local organization. You will also be accountable for the implementation of the premarket regulatory procedures and the compilation of regulatory clearance documentation to achieve timely regulatory clearances.

Tasks of a QARA Specialist:

- Promotes and assures quality of design and processes in line with the Quality Management System
- Participates as a mandatory core team member on 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
- Supports Sales and Service in dealing with quality and regulatory questions
- Ensures that Product Quality Strategy is completed compliantly and thoroughly
- Creates and maintains the key regulatory deliverables
- Verify that all risk mitigations are implemented in the course of the project
- Conducts and document quality planning for new products
- Reviews technical product documentation to ensure compliance with regulations
- Organize and escort internal and external regulatory inspections
- Identifies ongoing training needs of the team and provide training as required
- Define actions with involved department in case of process issues for related premarket/design control processes
- Ensures that the NC/CAPA process is followed as required and take actions in case of product or project issues
- Provides KPI data for internal reporting on project status and regulatory submissions as QMR and input for pre
- and post-market activities
- Performs project reviews/audits of technical documentation records as required
- Assure post-market surveillance and reporting obligations are complied with
- Reviews and audit related NCs and CAPAs
- Reviews and audit product labelling
- Verify the lifecycle, maintenance, and remediation activities of non-conform products
- Maintains all controlled document files and test records in a timely and accurate manner.
- Communication with notified body and competent authorities

Training/Knowledge/Experience

Prerequisites:

- Academic Degree in law, medicine, pharmacy, engineering or another relevant scientific discipline and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
or a Bachelor degree and at least four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- 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.
- Awareness of Medical Device product safety and Security Standards including ISO 27001 and GDPR
- Expert PC operation skills

Preferred:

- Knowledge of Design control regulations and requirements
- Ability to comply with medical device regulatory submission regulations and requirements
- Knowledge of Clinical risk management regulations and requirements
- Knowledge of CAPA/NC regulations and requirements
- Knowledge of usability, safety and product related standards
- Knowledge of software development methodologies and practices

Competencies
- Excellent organizational skills and attention to detail
- Analytically very strong
- Self-motivated and able to grasp new concepts and learn quickly
- Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
- Strong attitude in managing projects and deliverables with a high level of accuracy and completeness
- Ability to communicate technical information to development teams in a supportive and meaningful manner
- Able to motivate others and facilitate a positive work environment
- Excellent problem-solving ability
- Independent and sense of initiative
- Progressive and eager to learn
- Entrepreneurial and strong self-motivation

Languages
- Dutch: very good (verbal and in writing)
- English: very good (verbal and in writing)

Location: Dobco Office Zele

We offer
- An exciting job with a young and innovative company.
- An attractive salary with numerous fringe benefits, such as a company car, fuel card, hospitalisation insurance, group insurance, smartphone, laptop, meal vouchers, bonus scheme, etc.
- Flexible work schedules.
- Option of partially working from home
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