![Masimo Masimo](https://media.jobup.ch/media/53519775-60db-49a2-be89-922ff99e0dc2.jpg)
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.
Place of work
Route de Pierre-à-Bot 97
2000 Neuchâtel
Contact
Chloe Perno
Write an email
About the company
![Masimo Masimo](https://media.jobup.ch/media/53519775-60db-49a2-be89-922ff99e0dc2.jpg)
Neuchâtel / Europa