Duties & Responsibilities:
* Coordinate country submissions for Medical Devices in the EMEA region, ensuring compliance with regulatory requirements.
* Maintain and process regulatory certificates, including Free Sale Certificates, renewals, and changes, for EMEA and national requirements.
* Prepare and review regulatory documentation according to MDR obligations in the EMEA region, ensuring accuracy and completeness.
* Assist in registrations to the MDD/MDR in the EU and national requirements, achieving company objectives and timelines.
* Update technical documentation to reflect regulatory requirements, maintaining its accuracy and validity.
* Manage regulatory affairs files, listing information as required, and distribute it to relevant stakeholders.
* Proofread, assemble, route, and archive regulatory registration files, following established procedures.
* Maintain a schedule for the renewal of regulatory certificates and licenses, ensuring timely completion.
* Support distributor medical device registration activities by processing and tracking requests.
* Maintain published medical device registration records and databases in SharePoint, Salesforce, and Agile PLM, reflecting the latest regulatory approvals.
* Evaluate the impact of changes to Medical Devices on national regulatory requirements for assigned countries.
* Collaborate with customer service, marketing, and sales teams to review product shipments against product approvals.
* Arrange scheduling and meetings for regulatory affairs, supporting the team's efforts.
* Perform other duties or special projects as assigned by management.
Minimum Qualifications:
* Familiarity with global medical device regulations, requirements, and standards, such as ISO 13485, European Medical Device Directive, and Regulation (EU) 2017/745.
* Proficiency in Microsoft Office Suite, particularly Outlook, Excel, Word, and PowerPoint.
* Excellent verbal and written communication skills, enabling effective collaboration and stakeholder engagement.
* Prioritization, organizational, and interpersonal skills, with attention to detail and ability to work independently.
* Strong documentation skills, including record maintenance, tracking, and understanding of document traceability.
* A detail-oriented individual with a proactive attitude, capable of working in a team environment and autonomously with minimal supervision.
* Self-motivation, with ability to work in a matrix environment with non-local and local leadership.
* Fluent English verbal and written communication skills, essential for effective communication within the organization.
Preferred Qualifications:
* 2-5 years of related work experience, preferably within a medical device company.
* Prior experience working in an international organization, with a strong understanding of diverse regulatory environments.
Education:
Bachelor's degree, or equivalent combination of education and experience, is required. Preferred degrees in science, engineering, medical/healthcare, or regulatory science.