Duties & Responsibilities:
- Process requests for medical device regulatory documentation required by internal and external stakeholders.
- Process regulatory quotes, invoices, and other budgetary items.
- Assist in preparation of international medical device submissions to regulatory authorities.
- File regulatory records and update regulatory lists & databases.
- Support updating of product release status based on compliance with regulatory requirements.
- Support scheduling and arrangements for regulatory meetings.
- Monitor and maintain regulatory library of international medical device regulations and guidance documents.
- Perform general typing, data entry, filing, printing and copying regulatory submission documents, as needed.
- Process and distribute Regulatory Affairs incoming and outgoing mail or shipments.
- Maintain office supplies for regulatory submissions.
- Support Regulatory Affairs team with day-to-day projects, as needed.
- Perform other duties or special projects as assigned.
Minimum Qualifications:
- Two or more years of experience in quality or regulatory compliance related activities.
- Proficient in Microsoft Office Suite, in particular Outlook, Word, Excel, and PowerPoint.
- Proficient in document management systems.
- Excellent prioritizing, organizational and interpersonal skills.
- Excellent documentation skills including record maintenance/ tracking and understanding of document traceability.
- Ability to work in a fast-paced environment, with multiple tasks/projects.
- 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 and disciplined.
- Demonstrated ability to work in a matrix environment with non-local and local leadership.
- Excellent English verbal and written communication skills.
- Working proficiency in French or German preferred.
Preferred Qualifications:
- 3-5 years of related work experience within a medical device company.
- Proficient in document control systems, such as Microsoft SharePoint and Oracle Agile PLM.
- Prior experience working with international organizations.
- Knowledge of international regulatory requirements for medical devices.
Education:
- Bachelor's degree, or equivalent combination of education and experience is required. Preferred degrees in science, engineering, medical/healthcare or business.
Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?
Please send your full application.
To learn more about us, please visit: www.masimo.com