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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