Regulatory Affairs Manager for Medical Devices

Vor 6 Tagen

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

  • Lead, Manufacturing Engineering — Medical Devices

    vor 2 Wochen

    Winterthur, Schweiz R&D Med Solutions (Switzerland) AG Vollzeit

    A dynamic medical device manufacturer in Winterthur, Switzerland, is seeking a Team Leader in Manufacturing Engineering. This role involves leading a team of engineers, optimizing production processes, and ensuring compliance with regulatory standards. Ideal candidates will have a degree in engineering, strong troubleshooting and leadership skills, and...

  • Team Leader, Clinical Affairs

    vor 2 Wochen

    Winterthur, Schweiz Zimmer Biomet Vollzeit

    As a senior member of the clinical Post Market Surveillance Team, the Post Market Surveillance Team Leader will assume supervision role over a group of Post Market Surveillance Specialist team members ensuring timely and high quality in the execution of the tasks assigned to his/her direct reports. The Post Market Surveillance Team Leader is still directly...

  • Quality Assurance

    vor 1 Woche

    Winterthur, Schweiz Zimmer Biomet Vollzeit

    -Requisition Number EMEA10197 Employment Type Full-time Location Winterthur **Job summary**: This position will act as Management Representative and Person Responsible for Regulatory Compliance (PRRC) according to (EU) 2017/745 Medical Device Regulation Article 15, 3 (a), (c) & (d) for Zimmer Biomet Winterthur. Develops and implements local quality systems...

  • Quality Assurance

    vor 1 Woche

    Winterthur, Schweiz Zimmer Biomet Vollzeit

    **Requisition Number**: EMEA10197 **Employment Type**: Full-time **Location**: Winterthur **Job summary**: This position will act as Management Representative and Person Responsible for Regulatory Compliance (PRRC) according to (EU) 2017/745 Medical Device Regulation Article 15, 3 (a), (c) & (d) for Zimmer Biomet Winterthur. Develops and implements local...

  • Regulatory Affairs and Quality Manager 60-80%

    vor 1 Woche

    Winterthur, Schweiz Universal-Job Vollzeit

    **Beschreibung** In this role, you will ensure compliance with regulatory requirements in the markets. You will be responsible for the preparation of documentations in collaboration with manufacturers, the processing of new submissions and the logistics chain related to the marketing authorisation of medicinal products. You will also have legal...

  • Medical Manager

    Vor 4 Tagen

    Winterthur, Schweiz Hair and Skin Medical AG Vollzeit

    HAIR & SKIN ist ein junges Unternehmen im Bereich Medical Retail mit dem Ziel, schweizweit moderne und voll digitalisierte Kliniken in Fussgängerzonen zu eröffnen. Unsere Vision ist es, Behandlungen rund um Haut und Haar der breiten Masse zu fairen Preisen zugänglich zu machen und die erste Adresse für Haartransplantationen zu sein. **Für unsere...

  • Clinical Project Lead

    vor 2 Wochen

    Winterthur, Schweiz Zimmer Biomet Vollzeit

    The Clinical Project Lead (CPL) is responsible for broad aspects of clinical study development, initiation, monitoring and management. In addition and as requested by other teams especially by Clinical Strategy or Post Market Surveillance, the CPL will support new product development by counseling the team on relevant clinical aspects that needs to be taken...

  • Clinical Project Lead

    vor 2 Wochen

    Winterthur, Schweiz Zimmer Biomet Vollzeit

    **Job Summary**: The Clinical Project Lead (CPL) is responsible for broad aspects of clinical study development, initiation, monitoring and management. In addition and as requested by other teams especially by Clinical Strategy or Post Market Surveillance, the CPL will support new product development by counseling the team on relevant clinical aspects that...

  • Production Quality Expert 100%

    Vor 2 Tagen

    Winterthur, Schweiz Zimmer Biomet Vollzeit

    **Requisition Number**: EMEA09499 **Employment Type**: Full-time **Location**: Winterthur Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone...

  • Production Quality Expert 100%

    Vor 2 Tagen

    Winterthur, Schweiz Zimmer Biomet Vollzeit

    -Requisition Number EMEA09499 Employment Type Full-time Location Winterthur Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing,...