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.

EDUCATION:

  • Bachelor Degree in Science or Medical Technology.
  • Regulatory Affairs Certification (RAC) is a plus.

EXPERIENCE:

  • 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%.

SKILLS/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.

 

COMPANY OVERVIEW

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.