The VP will hold accountability for regulatory submissions, communications, and compliance including maintenance of registrations/licenses/accreditations. The position will be responsible for developing strong relationships with the FDA and other global regulatory agencies and will work on the development of regulatory policy with external groups
The candidate will also be responsible for building the appropriate sized internal support
and managing the external support to implement and execute the strategic plan to
ensure rapid and timely approvals that will lead to the achievement of Iris Dx's business
objectives. Reporting directly to the CEO, the VP will be a key member of Iris Dx’s
executive leadership team, making substantial strategic contributions beyond regulatory
● Provide management and leadership of the Regulatory Affairs department in the
development and implementation of regulatory strategies and processes to gain
product approvals worldwide
● Serve as point of contact and represent the Company before regulatory
authorities, including preparation of meeting agendas, materials, and minutes
● Monitor the regulatory process to ensure company compliance with all regulatory
commitments, obligations, and interactions
● Manage and oversee all operational aspects of regulatory submissions, including
maintaining timelines and developing and coordinating submission content for
various regulatory FDA, EMA, and PDMA applications, including IDEs, INDs,
PMAs, BLAs, dossiers, product registrations, MDRs and safety reports.
● Identify and assess regulatory risks for assigned projects or programs
● Represent Iris Dx at relevant conferences, tradeshows, and industry forums
● Demonstrate a solid knowledge and understanding of complex medical and
scientific subject matter as well as evolving regulatory policy and guidance and
ensure that staff is aware of new and existing relevant procedures, guidance and
● Some international travel may be required
● Effectively communicate with team, peers, executive management, and/or board
● Establish and manage the department budget to ensure that the department
● Develop and comply with company policies and procedures.
● Develop agreements and contracts in compliance with company procedure.
● Work with diverse stakeholders and build strong, collaborative relationships;
manage competing agendas and priorities across different functional
● Set direction and focus by leveraging organizational abilities and proactive
planning and oversee staff development and performance plans.
● Demonstrate cross-functional expertise and thrive in a highly complex
● Demonstrate strong analytical thinking, creative problem solving, organizational
and communication skills.
● Demonstrate unquestionable ethics, professional integrity, and personal values
consistent with the Iris Dx values
Education / Experience
Required: Bachelor's Degree in a scientific discipline
Minimum 5 years experience in regulatory affairs (regionally or globally)
Preferred: Advanced degree (MBA/MS/PhD/PharmD)
RAC accreditation is desirable
Applicants must be eligible to work in the United States without company sponsorship.
● Letter of Interest
● Name and contact information of three references