Regulatory Affairs Specialist

vor 1 Monat

Neuenburg, Schweiz Masimo Vollzeit

Duties & Responsibilities:

  • Preparation and coordination of country submissions for Medical Devices in EMEA.
  • Process and maintain EMEA, renewals, changes, Free Sale Certificates, and other regulatory certificates.
  • Prepare and review RA documentation according to economic operators ‘obligations under MDR in the EMEA region
  • Assist in registrations to the MDD/ MDR in the EU and to national requirements and international regulations, achieving company objectives and timelines in the EMEA region
  • Update of the technical documentation taking into account regulatory requirements
  • Maintain regulatory affairs files and listing and distribute information as required
  • Proofread, assemble, route, and archive regulatory registration files, as directed.
  • Maintain schedule for renewal of regulatory certificates and licenses.
  • Process and maintain requests to support distributor medical device registration activities, including the tracking of their registration activities.
  • Maintain published medical device registration records and databases in SharePoint, Salesforce and company document control system (Agile PLM) to ensure records reflect the latest regulatory approvals.
  • Assess impact of change to Medical Devices in respect of national regulatory requirements for assigned country
  • Support customer service, marketing, and sales with review of product shipments against product approvals.
  • Support scheduling and arrangements for regulatory meetings.
  • Support Regulatory Affairs team with day-to-day projects, as needed.
  • Perform other duties or special projects as assigned.

Minimum Qualifications:

  • Knowledge of appropriate global medical device regulations, requirements, and standards, such as ISO 13485, European Medical Device Directive and Regulation (EU) 2017/745, MedDO.
  • Proficient in Microsoft Office Suite, in particular Outlook, Excel, Word, and PowerPoint.
  • Excellent verbal and written communication skills.
  • Demonstrate prioritizing, organizational and interpersonal skills.
  • Documentation skills including record maintenance/ tracking and understanding of document traceability.
  • 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, ability to work autonomously.
  • Demonstrated ability to work in a matrix environment with non-local and local leadership.
  • Fluent English verbal and written communication skills

Preferred Qualifications:

  • 2-5 years of related work experience.
  • Prior experience working within a medical device company.
  • Prior experience working as part of an international organization.

Education:

Bachelor’s degree, or equivalent combination of education and experience is required. Preferred degrees in science, engineering, medical/healthcare, or regulatory science.

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