Regulatory Affairs Specialist

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.