Regulatory Affairs Manager for Medical Devices

vor 2 Monaten

Winterthur, Schweiz Acrostak Vollzeit

Acrostak is active in development, manufacturing and distribution of medical devices used for interventional cardiology. Our products comprise different types of angioplasty catheters to open occluded vessels as well as other high-tech devices in the field of mínimally invasive interventions. In order to strengthen our team in **Winterthur**, Switzerland, we are looking for a

**Regulatory Affairs Manager for medical devices**

**_Your profile: _**:

- _
- Bachelor’s or master’s degree in law, medicine, engineering or other relevant life science field
- Languages: English (main), German (is an asset)
- Experience of minimum 5 years in the regulatory field for medical devices (with adequate knowledge of QMS/ ISO 13485 requirements)
- Good knowledge of MDR 2017/745. Experience with submissions to Notified Bodies
- Good knowledge of USA regulatory system (e.g. direct involvement in 510K submissions)
- Knowledge of regulatory systems of other countries strongly appreciated (e.g. China,

Latin America, Japan etc.)
- Strong problem-solving skills
- Strong interpersonal skills
- Proactive and sales-oriented attitude
- Wish to work in an environment where there is room for optimization and improvement
- Ability to work independently
- Ability to understand and summarize technical and clinical data
- Ability to manage projects
- Computer literacy skills
- Good written and verbal communication
- Swiss nationality or Permit B or C or European citizen

**_Your tasks and responsibilities: _**:

- _
- Register new products in different regulatory systems directly with the local health authorities
- Write SOPs to improve processes
- Develop strategies for the most efficient registration pathways
- Monitor regulatory requirements worldwide
- Maintain current registrations worldwide and improve them as necessary
- Communicate with regulatory bodies
- Improvement and optimization RA department
- Research regulatory requirements and advise other departments of such requirements
- Complaints management, post-market surveillance, labelling requirements, distributorships, involvement in clinical aspects
- Working in collaboration with different departments, mainly QA
- Support S&M with specific regulatory needs from distributors/importers

Type d'emploi : 100%

Salaire : CHF100'000.00 à CHF150'000.00 par an

Programmation:

- Du Lundi au Vendredi
- Période de travail de 8 Heures
- Travail en journée

Formation:

- Baccalauréat universitaire (Exigé)

Expérience:

- MedTech RA (QMS/ ISO 13485, MDR, US 510K, Not Bodies): 5 ans (Exigé)

Langue:

- English (main), German (is an asset) (Exigé)

Permis/certificat:

- Degree in medicine, engineering, other life science (Exigé)
- Swiss nationality or Permit B or C or European citizen (Exigé)

Lieu du poste : En présentiel

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