7272 Garden Grove, CA 92841
Regulatory Affairs Specialist
General Job Description:
The Regulatory Affairs Specialist has a supporting role in the planning, coordination, and execution of Hycor’s global regulatory submissions. She/he must have excellent organizational skills, excellent verbal and written communication skills, have the ability to motivate and support teams and have in vitro diagnostic (IVD) technical skills and/or regulatory affairs operational skills. The Regulatory Affairs Specialist must have knowledge of applicable regulations and guidelines.
Write and prepare regulatory submissions and filings required for U.S. FDA and other international authorities (Pre-Sub, 510(k), CE technical documentation, MDR, Vigilance Reports, etc.)
Create, gather and compile technical documentation to support EU and International medical device registrations.
Act as member of project teams
Determine regulatory needs for new products and changes to existing products.
Prepare and compile documentation to maintain product registration files and electronic databases.
Review labeling and marketing materials for compliance with regulations.
Participate in inspections/audits by the notified body or other international agencies.
Support MDR, vigilance and recall related activities.
Develop and refine regulatory best practices, processes and procedures.
Keep current on global Regulatory requirements
Maintain a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to quality and integrity.
Support commercialization activities for product lines globally, according to local and regional regulatory and quality requirements.
Lead projects of various scope and size, as assigned.
Perform other duties, as required or assigned.
Have strong planning, organizational, and communication skills.
Have computer knowledge consisting of email, Word, Excel, Project, Visio, Adobe Acrobat Professional, and other basic skills.
Have excellent judgment, a positive driver attitude, be customer oriented, and a team player.
Skills and Abilities
Ability to work independently.Excellent oral, written, organizational, and analytical skills.Good understanding of IVD products, immunoassays, IVD instruments and software.Ability to represent the regulatory affairs department in frequent inter-organizational meetings.Ability to perform work with minimal direction and supervision.Ability to provide solutions to difficult technical issues associated with specific projects.
Bachelor Degree in Science or Medical Technology
Regulatory Affairs Certification (RAC) is a plus.
Minimum of 7 years of experience in diagnostics, life science, or medical devices with a minimum of 5 years in regulatory affairs. IVD experience is a plus.
Demonstrated ability to successfully support FDA submissions.
Demonstrated ability to work successfully on cross-functional teams.
Good knowledge of regulations such as CFR 801, 809 and 820
Working knowledge of IVDR and IVDD, ISO 13485, Quality System Regulation, and relevant international standards.
Working knowledge of medical device risk management standards and guidance documents, specifically ISO 14971.
Proven track record of maintaining regulatory knowledge and skills by participating in industry conferences/seminars.
Must be available and willing to work flexible schedules, as needed.
Must be able to travel, up to 15%
Prior experience with FDA submissions.
Strong working knowledge of problem solving and statistical methods, as applied to data included in regulatory submissions.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or regulations.
Ability to independently determine and develop approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives
Application Information & Contact (How to Apply)
To apply, please email resume to LCristobal@hycorbiomedical.com
Learn more about Hycor Biomedical here