Director, Regulatory Affairs

Job Overview

Diality is a medical device company focused on improving lives impacted by kidney disease. The company offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system.

Responsibilities

• Develops regulatory strategic plans and supports adherence with global regulatory requirements during product development, manufacturing, market launch, and post-market surveillance.
• Plans and prepares regulatory submissions for new products and product changes, including US FDA Investigational Device Exemption (IDE), US FDA 510(k), CE Marking under EU MDR, and 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 maintaining local, state, and national regulatory licensing and registration renewals, import/export permits, and other regulatory requirements.
• Affords regulatory assessments for product and manufacturing changes, prepares LTFs if necessary, and provides assistance and guidance regarding product labeling, marketing materials, and social media.
• Oversees Regulatory processes and systems, facilitates process improvement projects, and ensures compliance with ISO 14971.
• Supports Quality System projects such as complaint handling, post-market vigilance, and clinical follow-up activities, including related regulatory reporting.
• Participates in and reviews risk management activities/documents and ensures compliance with ISO 14971.
• Maintains a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to regulatory compliance, quality, ethics, and integrity.

Required Skills & Abilities

• Demonstrated excellence in developing global regulatory affairs strategies for medical products.
• 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.
• Proven track record of maintaining regulatory knowledge and skills by participating in industry conferences/seminars.
• 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.
• 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.

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.