QA/ra Officer
il y a 7 jours
At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates._
**Department Info**:
- In The Netherlands, after the integration of Quirem Medical in the Terumo Group in 2019, we have over 50 associates. Over 40 of us work in our site in Deventer, dedicated to the _**_Therapeutic Interventional Oncology _**_(TIO) product portfolio (Production, R&D, Clinical & Medical, QA, RA, Supply Chain and Support Services). In addition, we have several colleagues in sales, representing all Terumo products in The Netherlands as part of the Benelux sales organisation_
**Job Summary**:
- Support QA&RA manager in driving Quality & Regulatory compliance while aligning with the overall organization to meet business needs & objectives
- Support maintenance of Technical dossiers - including preparing necessary documentation - for all Quirem Medical’s products. Technical dossiers support global regulatory requirements for MD
- Monitor regulatory developments and assessing business impact, preparing related GAP-assessments and GAP-closure programs
- Assure Quality & Regulatory compliance in product and process development and change projects.
- Support initiatives to improve the quality and manufacturing efficiency of Quirem products.
- Be or become (lead) auditor for Quirem Medical’s QMS.
- Manage multi-disciplinary teams, supporting completion registrations, QMS and Technical Dossiers
**Responsibilities**:
- Support the preparation of an up-to-date Technical Dossier, Design History File, in accordance with the relevant regulatory requirements and standards for relevant jurisdictions (e.g. EU, USA, Canada) for all TIO’s products.
- Contribute to the QA&RA strategy related with a global marketing strategy of the TIO / Quirem Medical products, including defining the relevant regulatory frameworks and the product registration and technical documentation requirements.
- Maintain up-to-date QMS-documentation under responsibility of the QA/RA department. Proposes and implements optimizations where possible. Makes sure, procedural interactions within the QMS are identified and maintained in accordance.
- Coordinate - multidisciplinary and regional or global - projects to maintain or obtain regulatory approval or compliancy, in accordance with the business needs in countries or regions where TIO / Quirem Medical’s products are or will be marketed.
- Actively support the QA&RA manager in
- ensuring that the business remains compliant with local, federal and global quality system regulations applicable to the products manufactured, sourced by, distributed and installed or serviced by Quirem,
- Advising on Quality & Regulatory standards applicable to the business being served,
- Preparing GAP-assessments relevant for Quirem Medical’s business, resulting from new or changed Rules & Regulations or Standards,
- Coordinating, and executing GAP-closure projects/activities and changing existing or implement new procedures where required, consecutively,
- Resolving customer or supplier inquiries related with product quality
- or regulatory affairs related matters
- Act as an expert in the Quality & Regulatory function by actively supporting the development of Quality systems. Be able to implement and maintain a (new/revised) QS-platform.
- Ensure the proper implementation of and oversee CAPA (Corrective and Preventative Actions), validations, inspections, document control, regulatory affairs, and problem resolution, acting as an advisor. Maintains an effective CAPA process and CAPA e-platform.
**Profile Description**:
- Expertise demonstrated by either of the following qualifications (A or B):
- A) BSc/MSc degree or higher in science, engineering, medicine with 3+ years of relevant experience in medical device and 2+ years in regulatory affairs or QA&RA, including QMS
- B) 3+ years in pharma/biotechnology in a QA&RA function and 2+ years of relevant experience in medical device regulatory affairs, including QMS.
- The following expertise or experience is a must:
- In-depth knowledge of medical devices regulatory frameworks, considering:
- applicable standards such as ISO 13485:2016, ISO 14971:2019 or other applicable global quality and regulatory frameworks and standards
- Medical Devices Software product development and technical dossiers. Knowledge of relevant medical device software standards including IEC62304
- Medical Devices (class III, active implantable) in the EEA (incl. MDR, AIMDD, MDD).
- Knowledge regarding US FDA CFR and Health Canada regulation
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