Quality & Compliance Manager Medical Affairs

☞ Randstad Switzerland

Aussicht: 173

Update Tag: 29-03-2024

Ort: Bülach Zürich ZH

Kategorie: Qualitätssicherung / Qualitätskontrolle

Industrie: Staffing Recruiting Biotechnology Pharmaceuticals

Position: Mid-Senior level

Jobtyp: Full-time

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Jobinhalt

Do you have experience working in quality and clinical processes? Do you enjoy working in the medical device industry and are not afraid of taking on a new challenge?

In this case, you should have a look at this opportunity!

Our client, a world leading medical device manufacturer in Zürich area is looking for a:

Quality & Compliance Manager Medical Affairs

(Permanent position - to start ASAP)

Your Responsibilities
  • You will assure the compliance with guidelines, regulations and procedures in respect to clinical processes
  • You will work on quality process management and contribute to harmonization of QMS within global environment
  • You will perform quality checks internal and at the site
  • You will be responsible for training and qualification activities in respect to Medical Affairs department and regions
  • You will be performing and leading vendor qualifications/audits for external suppliers of clinical services
  • You will act as an interface between MA and its external stakeholders in regards to quality aspects in medium to high complex questions
  • You will be leading the execution of quality & compliance projects within the Medical Affairs department
Your Profile

Work experience:
  • 3-5 years proven experience in the medical device and clinical/regulatory field (i.e. clinical studies, post market surveillance etc.)
Competencies & Skills
  • University or bachelor’s degree in scientific, medical field or law or equivalent experience and background in medical or pharmaceutical within clinical studies and regulatory field required
  • Strong project and process management experience
  • Knowledge/Expertise in ISO 14155, MDD, MDR, GDPR, 21 CFR relevant parts, ISO 14971
  • Experience in (clinical) project work and experience as head of a work package within a project or programme
  • Detail oriented and communicative team player with strong project management skills
  • Strong self-starter and collaborator across all levels of the organization, within the business unit and with internal and external partners
Languages
  • Fluent in German and English (written and spoken) Experience as an internal auditor/co-auditor
Quality & Compliance Manager Medical Affairs

Do you have experience working in quality and clinical processes? Do you enjoy working in the medical device industry and are not afraid of taking on a new challenge?

In this case, you should have a look at this opportunity!

Our client, a world leading medical device manufacturer in Zürich area is looking for a:

Quality & Compliance Manager Medical Affairs

(Permanent position - to start ASAP)

Your Responsibilities
  • You will assure the compliance with guidelines, regulations and procedures in respect to clinical processes
  • You will work on quality process management and contribute to harmonization of QMS within global environment
  • You will perform quality checks internal and at the site
  • You will be responsible for training and qualification activities in respect to Medical Affairs department and regions
  • You will be performing and leading vendor qualifications/audits for external suppliers of clinical services
  • You will act as an interface between MA and its external stakeholders in regards to quality aspects in medium to high complex questions
  • You will be leading the execution of quality & compliance projects within the Medical Affairs department
Work Experience
  • 3-5 years proven experience in the medical device and clinical/regulatory field (i.e. clinical studies, post market surveillance etc.)
Languages
  • Fluent in German and English (written and spoken) Experience as an internal auditor/co-auditor
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Frist: 13-05-2024

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