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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