Regulatory Affairs Director

3 weeks ago

Irvine, California, United States Diality Full time

Job Title: Regulatory Affairs Director

Company: Diality Inc

Location: Irvine, CA

Job Type: Full-time

About Us: Diality Inc is a privately held medical device company committed to improving the quality of life for patients with kidney disease.

Job Description:

We are seeking a highly experienced Regulatory Affairs Director to oversee, develop, and influence regulatory policy and determine courses of action necessary to obtain regulatory clearance and approval for our medical devices.

Responsibilities:

  • Develops regulatory strategic plans and provides support to ensure adherence with global regulatory requirements.
  • Plans and prepares regulatory submissions for new products and product changes.
  • Serves as the primary contact with the US FDA and liaises with other country Regulatory Agencies.
  • Represents Diality in cross-industry regulatory initiatives.
  • Obtains and maintains regulatory licenses and registrations.
  • Assesses product and manufacturing changes and develops regulatory assessments.
  • Provides assistance and regulatory guidance regarding product labeling and marketing materials.
  • Provides oversight for Regulatory processes and systems.
  • Supports Quality System projects and activities.

Requirements:

  • Minimum science or engineering BS degree with at least 10+ years of medical device regulatory affairs experience.
  • Certification in regulatory affairs (RAC) preferred.
  • 2+ years of Regulatory Affairs leadership in a small/start-up company environment.

Experience and Skills:

  • Demonstrated excellence in developing global regulatory affairs strategies for medical products.
  • Strategic thinker, strong leadership and interpersonal communication skills.
  • US and EU medical device regulatory submission experience required.
  • Previous experience interacting directly with FDA is required.
  • Hands-on experience with 510(k) and Technical File/Design Dossier submissions.
  • Product development team experience.
  • Experience reviewing and approving technical documentation.
  • Broad based technical knowledge and skills in diverse areas of business.

Knowledge and Abilities:

  • Comprehensive knowledge of laws and regulations applicable in an FDA-regulated environment.
  • Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations.
  • Knowledge and understanding of other foreign country regulations and international device registration a plus.
  • Good knowledge of clinical evaluation and investigation of medical devices.
  • Excellent interpersonal skills including ability to interact with a high degree of diplomacy.
  • Excellent problem-solving, applied thinking and technical writing skills.
  • Excellent communication and organization skills required.
  • Ability to work in a fast-paced, technically challenging environment.
  • Expertise in Microsoft Office and Adobe Acrobat applications.

Physical Demands:

  • Prolonged periods of sitting at a desk and working on a computer.
  • May be expected to lift 15 pounds at times.

Working Environment:

  • Office or work-station environment.
  • Remote work environment is also an option for this position.

Travel:

  • Ability to travel (domestic and international) as required, approximately 10%.

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