Director, Regulatory Affairs in Irvine, California at DIALITY INC

Company & Job Overview

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Regulatory Affairs Director is responsible for overseeing, developing, and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory clearance and approval for the Diality products. The Regulatory Affairs Director is responsible for planning and executing regulatory activities necessary to obtain and maintain regulatory approvals within the United States and other countries. This position is also responsible for supporting the Quality Management System and will serve as the Regulatory Affairs lead on product teams. The Regulatory Affairs Director will also act as the Regulatory Responsible Person as defined by the EU MDR.

Responsibilities

• Develops regulatory strategic plans and provides support to ensure adherence with global regulatory requirements as appropriate. Supports overall regulatory strategy during product development, manufacturing, market launch, and post-market surveillance.
• Plans and prepares regulatory submissions for new products and product changes to ensure timely approval for clinical studies and market release that include, but are not limited to, the following:
  1. US FDA Investigational Device Exemption (IDE)
  2. US FDA 510(k)
  3. CE Marking under EU MDR
  4. Product amendments to existing regulatory approvals/clearances
• Serves as the primary contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies, when needed, directly or in coordination with local country representation.
• Represents Diality in cross-industry regulatory initiatives
• Responsible for obtaining and maintenance of, but not limited to, the following:
  1. Local, State and National Regulatory licensing and registration renewals
  2. Import/Export Permits
• Assesses product and manufacturing changes and develops regulatory assessments for each market as to impact upon current approvals. Prepares well-justified Letters to File (LTFs) if appropriate.
• Provides assistance and regulatory guidance regarding product labeling, marketing materials and social media.
• Provides oversight for Regulatory processes and systems. Facilitate and support the implementation of various Regulatory process improvement projects by working directly with key stakeholders to accelerate market access routes and ensure compliance. Lead compliance initiatives relating to Regulatory requirements.
• Supports Quality System projects and activities such as, but not limited to, the following:
  1. Complaint Handling
• Supports Clinical and Commercial functions in post-market vigilance and clinical follow-up activities, including related regulatory reporting.
• Provide Oversite and acts as the primary interface with regulatory and other party certification agencies in Product Recalls, Field Related activities and Corrections and Product adverse event reporting collaborate with and supported by Director of Quality
• Leads inspections/audits by the notified body or other international regulatory Agencies by producing requested documents or answering any inquiries for information.
• Supports the Director, Quality during internal and external (i.e. FDA, etc.) Quality inspections/audits.
• Participates in and review risk management activities/documents and ensure compliance with ISO 14971.
• Monitors product development, manufacturing, and post-market data to ensure appropriate updates to the risk management, design history, technical files, and post-market surveillance reports are incorporated in a timely manner.
• Maintains a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to regulatory compliance, quality, ethics, and integrity.

Required Skills & Abilities

Education & Experience

• Minimum science or engineering BS degree with at least 10+ years of medical device regulatory affairs experience or a Regulatory Affairs MS or PhD with at least 7+ 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, as demonstrated by previous employment roles and responsibilities
• Previous experience interacting directly with FDA is required
• Experience reviewing and approving technical documentation
• US and EU medical device regulatory submission experience required
• Hands-on experience with 510(k) and Technical File/Design Dossier submissions
• Strategic thinker, strong leadership and interpersonal communication skills, assertiveness, strong technical background, strong analytical skills, well organized, and excellent negotiation, and project management skills as a regulatory lead on projects
• Product development team experience

Travel

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

Physical Requirements

• 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

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.