Company & Job Overview:
Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.
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.
Duties & 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:
a. US FDA Investigational Device Exemption (IDE)
b. US FDA 510(k)
c. CE Marking under EU MDR
d. 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:
- Local, State and National Regulatory licensing and registration renewals
- 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:
- 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.
Qualification Requirements:
- 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
Experience and Required Skills:
- Demonstrated excellence in developing global regulatory affairs strategies for medical products
- Demonstrated excellence in developing global regulatory affairs strategies for medical products
- 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
- 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 such as Engineering, Operations, Quality, Marketing, Clinical Research, etc.
- Ability to effectively negotiate and influence cross-functional stakeholders, affiliates, and Regulatory authorities is a plus
- Proven track record of maintaining regulatory knowledge and skills by participating in industry conferences/seminars
Knowledge & 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 where drive is critical to success
- Expertise in Microsoft Office and Adobe Acrobat applications
- Familiarity with dialysis and end-stage renal disease is a plus
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%
