Regulatory Affairs Specialist

☞ Masimo

Ver: 188

Dia de atualização: 29-03-2024

Localização: Neuchâtel Neuchâtel NE

Categoria: Legal / Contratos

Indústria: Information Technology Services Medical Devices Hospital & Health Care

Posição: Entry level

Tipo de empregos: Full-time

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Conteúdo do emprego

Job Summary

Job Description

Located in the Neuchatel, CH Masimo International Office, the Regulatory Affairs Specialist provides support to the Regulatory Affairs department for the Europe and Africa regions. Key responsibility is to assist with tracking and facilitating external requests for regulatory support, maintain regulatory submission files and registration records, and perform administrative functions as needed by the Global Regulatory Affairs team.

Duties & Responsibilities
  • Process requests for medical device regulatory documentation required by internal and external stakeholders.
  • Process regulatory quotes, invoices, and other budgetary items.
  • Assist in preparation of international medical device submissions to regulatory authorities.
  • File regulatory records and update regulatory lists & databases.
  • Support updating of product release status based on compliance with regulatory requirements.
  • Support scheduling and arrangements for regulatory meetings.
  • Monitor and maintain regulatory library of international medical device regulations and guidance documents.
  • Perform general typing, data entry, filing, printing and copying regulatory submission documents, as needed.
  • Process and distribute Regulatory Affairs incoming and outgoing mail or shipments.
  • Maintain office supplies for regulatory submissions.
  • Support Regulatory Affairs team with day-to-day projects, as needed.
  • Perform other duties or special projects as assigned.
Minimum Qualifications
  • Two or more years of experience in quality or regulatory compliance related activities.
  • Proficient in Microsoft Office Suite, in particular Outlook, Word, Excel, and PowerPoint.
  • Proficient in document management systems.
  • Excellent prioritizing, organizational and interpersonal skills.
  • Excellent documentation skills including record maintenance/ tracking and understanding of document traceability.
  • Ability to work in a fast-paced environment, with multiple tasks/projects.
  • A detailed-oriented individual with a “can do” attitude and ability to work in a team environment as well as individually with minimal supervision.
  • Self-motivated and disciplined.
  • Demonstrated ability to work in a matrix environment with non-local and local leadership.
  • Excellent English verbal and written communication skills.
  • Working proficiency in French or German preferred.
Preferred Qualifications
  • 3-5 years of related work experience within a medical device company.
  • Proficient in document control systems, such as Microsoft SharePoint and Oracle Agile PLM.
  • Prior experience working with international organizations.
  • Knowledge of international regulatory requirements for medical devices.
Education
  • Bachelor’s degree, or equivalent combination of education and experience is required. Preferred degrees in science, engineering, medical/healthcare or business.
Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?

Please send your full application.

To learn more about us, please visit: www.masimo.com

About Us

For over thirty years, Masimo has been expanding the boundaries of noninvasive monitoring to improve patient outcomes and reduce the cost of care. Today, Masimo delivers a portfolio of hospital-trusted monitoring solutions to help increase patient safety, health, and wellness in the hospital and at home. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others.
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Data limite: 13-05-2024

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