Director of Regulatory Affairs

26 Aug, 2020

Jobs

Director of Regulatory Affairs

Fluxergy
Irvine, CA

The Director of Regulatory Affairs will be an integral part of an expanding regulatory affairs team that is responsible for developing, maintaining and documenting our mission critical regulatory filings and registrations. You will be expected to lead a cross discipline team supporting the quality systems and regulatory requirements for the organization.

Work can include: Supporting Fluxergy with ISO 13485:2016 and MDSAP requirements; interfacing with, preparing, and submitting applications for, the USDA, FDA 510(k)s, and CE markings; supporting the creation and maintenance of design history files; supporting regulatory affairs for new product development; monitoring, and supporting quality systems for manufacturing and new product development. Personality traits include people who are have leadership and regulatory expertise, organizational abilities, and multi-tasking skills.

Responsibilities:

  • Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes.
  • Responsible for Company’s US FDA Regulatory filings, be the liaison with the regional regulatory affairs team to help obtaining the required regulatory approvals to market the Company’s products worldwide.
  • Represent Regulatory Affairs on project team and management review meetings.
  • Review advertising, labeling and public communications for regulatory compliance issues.
  • Assist in ensuring compliance to design control regulations during product development and delivery activities.
  • Assist in developing regulatory strategy for new products and claims.
  • Responsible for keeping management team informed of regulatory status of products and significant regulatory issues.
  • Provide counsel, training, and interpretation of regulatory requirements to company personnel and assist as a liaison between the company and regulatory bodies.
  • Support the quality management system to ensure regulatory compliance.
  • Perform other responsibilities as required.

Requirements:

  • Must be a creative thinker with the ability to develop regulatory strategies by thinking out of the box.
  • Detailed orientated and organized with a proven ability to create processes which teams can follow.
  • Proficient Microsoft Office Suite
  • Excellent speaking and presentation skills
  • Experience with FDA submissions and EU Technical files
  • Experience with EU MDR

Job Type

Full time, Exempt

Experience:

  • Experience with all three classes (i.e., class 1, 2 and 3 devices) of medical devices is preferred
  • Demonstrated knowledge of FDA and EU regulation for medical devices, with some high-level understanding of global regulatory affairs is required
  • Experience with Change management and quality systems.
  • Experience with USDA veterinary biologics desirable.

Education:

Minimum Bachelor’s degree with at least 10 years of professional experience with medical devices.

Note: No agencies! All candidates/resumes submitted by an agency or 3rd party will be considered a referral.

Job Type: Full-time

Pay: From $1.00 per hour

Benefits:

  • 401(k)
  • Dental Insurance
  • Flexible Schedule
  • Health Insurance
  • Life Insurance
  • Paid Time Off
  • Vision Insurance

Schedule:

  • Monday to Friday

COVID-19 considerations:
Face masks are required. We provide sanitation stations at each main point of entry which includes disposable face masks, disposable gloves, tissues, and hand sanitizer.

Learn more here

Job posted: 2020-08-26