Senior Regulatory Affairs Specialist
Company: Hycor Biomedical
Position: Regulatory Affairs
Location: Garden Grove, CA
Posted: March 3, 2021
The Senior 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 Senior Regulatory Affairs Specialist must have knowledge of applicable regulations and guidelines.
The Senior Regulatory Affairs Specialist, through individual contribution will:
- 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.
- 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.
- 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.
- Must be available and willing to work flexible schedules, as needed.
- Must be able to travel, up to 15%.
- 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.
Founded in 1981, HYCOR Biomedical, Garden Grove, CA, is a global manufacturer and marketer of in vitro diagnostic products. Since its founding, HYCOR has served the allergy diagnostic testing needs of clinical laboratories, hospitals and doctors' offices worldwide. The recently launched NOVEOS™ builds upon 40 years of experience in specific IgE testing, and supplements the Company’s existing line of HYTEC® products. The company is focused on delivering NOVEOS, a new generation fully-automated allergy system that solves the shortcomings of today's technology, with 1/10th the sample requirement and negligible interference issues.