Global Regulatory Coordinator

vor 2 Monaten

Neuenburg, Neuenburg, Schweiz Sound United Vollzeit

Job Summary:

Sound United is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with global medical device regulations and standards.

Key Responsibilities:

  • Prepare and coordinate country submissions for Medical Devices in the EMEA region.
  • 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.
  • Primary contact for regulatory issues: clarifies, informs, documents, and provides expert guidance on complex regulatory concepts to cross-functional teams.
  • Assist in ensuring compliance 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 the 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 complete distributor letters for: distribution agreements, power of attorney, authorizations to register, product lists, market history, etc.
  • Maintain published regulatory records and databases in SharePoint, Salesforce and company document control system (Agile PLM) to ensure latest regulatory approved revisions are presented.
  • Assess impact of change to Medical Devices in respect of national regulatory requirements.
  • Support customer service, marketing, and sales with global market approvals for product shipments.
  • 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.

Requirements:

  • Knowledge of appropriate global medical device regulations, requirements, and standards, such as ISO 13485, European Medical Device Directive and Regulation 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.
  • Proficient in Salesforce and document control systems, such as Microsoft SharePoint and Oracle Agile PLM.
  • Prior experience working with international organizations.
  • Prior experience working within a medical device company.

Education:

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

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