Tasks include:
o Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide.
o Support the preparation of dossiers and submission packages for regulatory agencies, including IVDR Technical Dossiers for CE Mark approval.
Coordination with partner channel regulatory colleagues to obtain product approvals.
Organize, update, and maintain regulatory documentation in accordance with department and company procedures including maintaining logs and trackers.
Maintain positive and cooperative communications and collaboration with all levels of employees and partners
Request and track document legalization, apostille and requests for certificates from regulatory agencies.
Process change orders for approval of documentation in electronic records management system
Perform other related duties and responsibilities, on occasion, as assigned.
Keys to Success:
A bachelor's degree with a preference for majors in Science or Engineering is required.
Experience and excellent understanding of EU IVD regulation
Excellent verbal and written communication skills, and attention to detail.
Multitasks, prioritizes and meets deadlines in timely manner.
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
Strong verbal communication with ability to effectively communicate at multiple levels in the organization
Must be able to write clear, understandable technical documentation, i.e. regulatory documentation
Proficient in MS applications (Excel, Word, Outlook).
This position is on site at Fremont, California facility
Exact Schedule - M-F 8am-5pm
...Job Title: Salon Receptionist & Administrative Assistant Location: Felangi Salon, Downtown Boise Job Type: Full-Time Reports to: Salon Manager/Owner Job Summary: Felangi Salon, a highly-rated salon known for exceptional client satisfaction, is seeking...
Role: Data Engineer Location: Cincinnati OH (Day 1 onsite) Skills: Databricks/Snowflake Azure Github Azure Data Factory Data Warehousing ETL.ELT CI/CD SQL Job Description Minimum 3 years of experience in Data Engineering role that involves Analyzing...
...Summary Become a Real Estate Consultant with Us Embrace the chance to work alongside and learn from the leading 20% of real estate experts in North America. As a Real Estate Consultant, you'll have the opportunity to elevate your career with our team. We offer a...
...who reside in the United States. About Our Process We are NOT a content mill; we are a small, specialized content marketing agency that produces high-quality content for companies helmed by thought leaders. Were always onboarding new clients. Should we...
Qualifications\ Experience:\ receptionist or customer service, 1 year (Preferred)\\ Full Job Description\ Muse Cosmetic Institute is looking to add a new Salon Coordinator to its team. You must be able to multi-task in a busy environment while maintaining a high...