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Regulatory Affairs Coordinator
vor 2 Monaten
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sound United. The successful candidate will be responsible for ensuring compliance with EU regulations and standards, including the Medical Device Regulation (MDR) and the European Medical Device Directive (MDD).
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.
Requirements:
- 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.
- 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.
