Product Reviewers for Non-active Implantable

vor 2 Wochen

Alle JU, Jura, Schweiz TUV SUD Danmark ApS Vollzeit
PRODUCT REVIEWERS FOR NON-ACTIVE IMPLANTABLE (CARDIOVASCULAR AND NEUROVASCULAR) MEDICAL DEVICES - TÜV SÜD DENMARK MHS

AUFGABEN
Planning and conducting product related assessment according to MDR 2017/745.


Draw up records and reports such as technical assessment report demonstrating that the relevant conformity assessment activities have been appropriately carried out.

For product reviewers with relevant MDR codes; interactions with authorities for products covered by special procedures.

Participate in identifying, selecting and review subcontractors.


Identifying the activities, milestones, duration and competences needed within knowledge area for the entire conformity assessment project as part of establishing the project plan.

Coordinate own conformity assessment activities with relevant departments and stakeholders.

Advise the audit team, and in particular the audit team leader, on aspects of the manufacturer's design or production processes which could be of particular relevance for the on-site audit

Deliver according to agreed project plan.

Take part in processing appeals or complaints.


Conducting assessment and verification activities oncertified product(s) or device range covered by certification, for changes and/or modifications on manufacturers products.

Training of colleagues if needed to share and build up a wider knowledge base

Support Head of certification in vigilance information evaluations.

QUALIFIKATIONEN

Background education
University (B.Sc.) or technical college degree in relevant studies such as medicine, pharmacy, engineering, or other relevant sciences.

Work experience
Min.

4 years of work experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research.

Min.

2 of the 4 years shall be in the design, manufacture, testing or use of the device or technology to be assessed, or gained the experience as an assessor for a medical device notified body.


Practical experience in conducting testing or assessment technical files, addressing aspects of the device such as, but not limited to; biological safety, physical, chemical and microbiological characterization, electrical safety, and electromagnetic compatibility, software verification and validation, stability, shelf life, performance and safety.

Assessing technical files for pharmaceuticals will also fulfill the requirement.

Qualification and skills
Strong knowledge in the medical device standards, CS and EU device legislation

Sound knowledge of standards related to biocompability (the ISO 10993 series of standards) and risk management for medical devices (ISO

Excellent verbal and written communication skills in English

Analytical skills

Detail oriented

ability to work in a team

WEITERE INFORMATIONEN

Other values that we believe are important to succeed in the roleinTÜV SÜD Denmark MHS are:

Be a true team worker;
Share, care for and develop our values of diversity and inclusion in society and our work environment

Actively enabling other team members to grow in competence and work as one team towards a common goal

Extending friendliness and mutual respect to partners and colleagues.

Customer orientation;


Deliver customer-centric service for our clients by having well-developed communication and listening skills, assuring a transparent and customer-orientated service for our clients.


In possession of a business mindset that shows interest and understanding how TÜV SÜD Denmark MHS can further grow together with client needs.


Intrinsic strengths;
Transparency and honesty

Integrity

Curious to learn new abilities

Having a "can-do" mentality

Good self-awareness by the means of having or being;
Self-critical

Dedicated to self-improvement

Ability to listen

Able to manage uneven workload

Self confidence

Location:
Home office or at one of our TÜV SÜD offices - To be discussed dependent on place of residence

Details zur Ausschreibung
***:

BESCHÄFTIGUNGSART:

  • Vollzeit / Unbefristet
    ARBEITSMODELL:
  • Homeoffice
    STANDORT:
  • Alle Standorte
    LAND:
  • Europa
    EINSATZBEREICH:
  • Medizintechnik & Gesundheitswesen
    BERUFSERFAHRUNG:
  • Berufserfahrene mit 35 Jahren Erfahrung
    GESELLSCHAFT:
  • TUV SUD Danmark ApS
    ORGANISATIONSEINHEIT:
  • TUV SUD Danmark ApS
    KENNZIFFER:
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