iLocatum

Irvine, CA

Regulatory Compliance (LR-22905)

Job Title: Regulatory Affairs Specialist

Job Responsibilities:

This role involves advisory support for regulatory requirements and assisting in regulatory projects and tasks to ensure compliance with FDA regulations, ISO standards, and other regulatory agencies.

General Description and Duties:

To excel in this position, an individual must successfully complete each essential job task. The tasks listed below represent the necessary knowledge, skill, and ability. Reasonable accommodations can be made to assist individuals with disabilities in performing the essential functions.

  • Guidance provided on regulatory requirements necessary for strategic and contingency planning, including the development of regulatory strategic plans for team solutions.
  • Representation of regulatory affairs on teams involved in product development and commercialization.
  • Ensuring compliance with standards and execution of corrective actions, acting as the liaison with domestic and international customers and vendors.
  • Preparation and oversight of documentation packages for submission to global regulatory agencies. Tracking timelines and documenting milestone achievements for inclusion in regulatory submissions. Interacting with regulatory agencies during submission review and on-site audit support (e.g., IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files).
  • Assisting with customer complaints/CAPA system.
  • Developing a risk assessment review process for all marketed devices and implementing changes to the risk management process as required.
  • Monitoring proposed and current US and EU regulations and providing advice on the impact of such regulations.
  • Reviewing documents for regulatory claims, promotional material, labeling content, product and process changes, and product documentation.
  • Collaborating and receiving direction from RA management.

Projects and Other Duties:

  • Performing additional assigned duties.

Position Qualifications

  • Strong working knowledge of US and EU regulations impacting Class III medical devices.
  • Experience working on cross-functional projects.
  • Proficient in English with excellent written and verbal communication skills.
  • Strong analytical thinking and problem-solving skills.

Minimum Education:

  • Bachelor's degree in a related field, preferably in a scientific discipline.

Minimum Experience:

  • 3 years of experience in a regulatory role or related area.

Salary:

Aligning our overall business objectives with performance and merit-based pay, Our Client offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $80,000 to $120,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
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