Job Details
Reporting directly to the Chief Operating Officer, the Director of Regulatory Affairs assumes responsibility for guiding regulatory strategies, providing support for quality systems, and offering expertise across various functions to bolster the expanding range of cutaneous neurodiagnostic products. These products, presently classified as laboratory-developed tests (LDT) in the US, necessitate adept management of regulatory processes, particularly for medical devices, in vitro diagnostics, and software-based medical products, ensuring compliance with both US and EU markets. The Director will engage external consultancies to aid in meeting Medical Device & In Vitro Diagnostics regulatory standards for the EU and act as the principal liaison for all related undertakings, including interactions with EU-notified bodies.
In parallel, the Director will collaborate on establishing procedures that align with existing laboratory quality systems standards for both commercial and research testing in the US. Moreover, the Director will spearhead efforts to anticipate and adapt to potential regulatory shifts, preparing for a prospective transition from LDT designation to FDA-governed Medical Device/In Vitro Diagnostics classification. Integral to the role is the operational implementation of day-to-day activities to ensure regulatory compliance company-wide, in coordination with personnel responsible for specific elements of the laboratory quality system. Additionally, overseeing and directing the work of external regulatory and quality consultants will be crucial for achieving desired outcomes.
Job Responsibilities General Duties:
- Act as the primary authority on US and EU regulatory strategies and requisites for the portfolio of cutaneous neurodiagnostic products, collaborating closely with company executives to devise effective regulatory plans.
- Develop strategic roadmaps for regulatory clearance of products in the R&D pipeline, regularly liaising with key commercial and R&D stakeholders to provide insights on potential regulatory considerations.
- Represent the company in engagements with regulatory authorities, playing a pivotal role in negotiations pertaining to regulatory strategy for product submissions.
- Facilitate interactions with regulators, coordinating meetings and preparing company personnel for engagements.
- Collaborate with the quality team to ensure alignment with laboratory quality requirements, working towards appropriate ISO certifications.
- Maintain regular and effective communication with senior leadership and functional teams, incorporating feedback as necessary.
- Interpret and communicate the impact of statutes, regulations, policies, and guidelines on product development, manufacturing, and marketing.
- Independently manage multiple projects simultaneously, ensuring focused urgency as required by specific events.
- Work closely with the quality team to uphold necessary documentation standards.
- Undertake other duties as assigned.
EU and International Markets:
- Assist in developing regulatory strategies for product commercialisation in the EU and other international markets.
- Collaborate with company leaders to establish ISO certification and other requisite protocols for international markets.
- Prepare technical documentation for CE marking, adhering to EU MDR and IVDR requirements.
- Oversee processes to maintain quality and regulatory compliance, interfacing with Notified Bodies as needed.
- Provide subject matter expertise during Technical Audits by Notified Bodies.
US Market:
- Collaborate with company leadership to develop regulatory strategies for the evolving product portfolio.
- Maintain relations and compliance with laboratory regulatory and certification bodies in collaboration with relevant company leadership.
- Prepare regulatory submissions to FDA, including Q-submissions, 510(k), and/or PMA submissions.
- Provide risk assessments of strategies and regulatory options to cross-functional teams.
- Collaborate with relevant teams to maintain quality systems and improve processes.
- Stay abreast of FDA requirements, guidance, and developments related to IVD and LDT products.
Key Requirements:
Knowledge, Skills & Experience:
- 10-15 years of quality and regulatory experience within the international medical device or medical diagnostics sector.
- Direct experience interfacing with regulatory and accrediting agencies, including FDA and European notified bodies.
- Experience in team management and leading cross-functional projects.
- Technical proficiency in regulatory requirements, including FDA-IVD, EU-IVDR, and ISO.
- Ability to interpret and apply regulations effectively.
- Experience in preparing and filing regulatory submissions for medical device or medical diagnostics companies.
- Strong communication, problem-solving, organizational, and planning skills.
- Proficiency in Microsoft Office Suite and document control systems.
Education, Certifications, and Licensures:
- Bachelor s degree in a science-related field.
- Relevant professional certifications required, with ongoing support from the company.
Special Training:
- Completion of company-specific manager training.
Other:
- Position based at the company headquarters in Scottsdale, Arizona, with onsite work expected 3-4 days per week. Exceptions for remote work may be considered for exceptional candidates.
Physical Demands:
- Ability to use office equipment and maintain visual acuity for detail-oriented tasks.
- Ability to sit or stand for extended periods and perform repetitive motions.
- Potential exposure to biohazardous materials in a lab environment.
Please feel free to reach out to me directly at ...@hartmannyoung.com for a confidential discussion.