[Remote] Director, Global Regulatory Affairs IVD

Note: The job is a remote job and is open to candidates in USA. RQM+ is The MedTech CRO, accelerating innovation to patient impact. The Vice President, IVD Global Regulatory Affairs is a senior technical leader responsible for strategic oversight and direct client delivery of regulatory, quality, and clinical solutions for IVD products across the United States and European Union. Responsibilities • Serve as the technical authority for IVDs across US and EU markets, including regulated IVDs, Laboratory Developed Tests (LDTs), and Companion Diagnostics • Lead and execute complex, high-risk, or novel IVD engagements targeting FDA and EU IVDR approval • Perform direct, billable client work on advanced regulatory, clinical, and performance evaluation programs • Develop and execute US and EU regulatory strategies, performance evaluation plans and reports (PEPs/PERs), and clinical evidence approaches • Act as senior technical reviewer for critical submission deliverables • Support and lead FDA interactions and EU Notified Body engagements • Translate regulatory changes, guidance, and policy updates into practical, actionable guidance for clients and internal teams • Define, evolve, and standardize IVD technical solution offerings aligned with FDA and EU IVDR expectations • Shape technical approaches, scope, and resourcing for proposals and statements of work • Participate in technical discovery discussions and senior-level, client-facing engagements • Establish technical standards, templates, tools, and best practices across IVD programs • Mentor, coach, and technically guide IVD consultants and project teams • Support hiring, onboarding, and professional development of IVD technical staff • Contribute subject matter expertise to RQM+ technical training programs and learning initiatives • Act as a visible and credible representative of RQM+ within the IVD and medical device regulatory community • Speak on behalf of RQM+ at key industry conferences, congresses, and regulatory forums • Develop and deliver webinars, white papers, blogs, and conference presentations • Participate in industry committees and working groups relevant to IVD regulation • Provide proactive technical and regulatory insight to the SVP, Intelligence and Innovation and RQM+ Executive Team on industry trends, regulatory changes, market opportunities, and business risks • Monitor competitor activity and evolving regulatory landscapes to identify threats and growth opportunities • Guide the development of intelligence reports supporting RQM+ business expansion and commercialization strategies • Identify opportunities for technical quality improvements and regulatory solution innovation • Partner with Division leaders to support marketing strategies and positioning of IVD services • Leads efforts in planning, execution, and interpretation of clinical research requirements • Oversees and approves implementation and delivery of regulatory strategies of clinical protocols • Oversees development, implementation and maintenance of appropriate standard operating procedures and policies to ensure compliance with regulations, guidelines and standards related to clinical research studies • Stays current with market, clinical, regulatory, and quality developments • Routinely interacts with and reports to executive-level management on progress of Regulatory Affairs programs and studies • Collaborates with Regulatory and Quality Affairs and R&D to transition preclinical studies to clinical Regulatory Affairs for product development and to develop clinical studies to support regulatory approvals across multiple geographies • Ensures Regulatory Affairs is effectively represented in new product development activities • Develop and maintain Regulatory Strategies to release and maintain product in accordance with the Standards and Regulatory requirements • Interface with regulatory agencies such as FDA and Notified Bodies (NB) • Provide RA leadership/support to New Product Development (NPD) teams • Provide strategic direction on labeling, regulations, and standards • Support the regulatory aspects of medical devices and/or diagnostic devices across a range of classifications • Collaborate cross-functionally with R&D, manufacturing, medical, clinical, non-clinical and marketing to incorporate their reports into submissions • Create, edit, review, and maintain regulatory submissions to support country specific marketing approval. Ex: Technical Documentation, Design Dossiers, 510(k), IDE, PMA, de novo, etc • Submit and/or review PMAs/supplements/30-day notices • Obtain approvals for new medical devices, and/or SW and/or diagnostics and determine regulatory impact of design/process changes • Maintain product registration and review changes and registration updates as required to either regulators or NBs • Develop, maintain, review, product labels, Instructions for Use (IFU) and any associated marketing material for compliance with applicable regulations and technical standards • Participate in strategy development for reimbursement • Perform gap assessments and propose remediation for regulatory submissions including technical files to EU MDR and/or IVDR • Support International Registration Requests and coordinate device change communication to regulatory agencies across the globe as necessary • Participate in project development teams and reviews plans, reports, risk management and design reviews associated with product and process projects intended for inclusion in regulatory submissions • Provide acquisition due diligence and integration • Review and provide input on clinical trials required for strategy development Skills • A university degree or equivalent qualification in relevant sciences such as: Chemistry, Biochemistry, Biology, Microbiology, Genetics, Biotechnology, Biomedical Sciences required • Minimum 10 years' relevant postgraduate clinical, technical, regulatory, or related experience, required; of which a minimum 5 years in the design or clinical application of IVDs (preferred) • Minimum 5 years' experience in a technical or regulatory leadership role relevant to the in-vitro diagnostics industry required • Extensive knowledge of In Vitro Diagnostic Regulations (EU MDR/IVDR) and/or FDA Regulations required • Demonstrated, hands-on experience authoring and executing US and EU IVD regulatory deliverables • Deep working knowledge of FDA IVD regulations and EU IVDR requirements • Experience supporting FDA meetings and EU Notified Body interactions • Experience with Companion Diagnostics, LDTs, and clinical trial assays • Strong Business Acumen, with the ability to think strategically and respond appropriately to leadership, customer, and employee needs • Ability to collaborate with cross-functional teams to produce high quality work and recommendations • Can distill large amounts of clinical, regulatory, and market data; interpret and translate data into insights and recommendations • Ability to educate and motivate others through targeted content, sound facilitation and coaching skills, and engaging approaches • Innovation Management: ability to bring creative ideas of others to market and has good judgment about which ideas/suggestions will benefit the company • Advanced degree preferred (MS, PhD or equivalent experience) in a relevant scientific discipline required (e.g., Chemistry, Biochemistry, Biology, Microbiology, Genetics, Biotechnology, Biomedical Sciences) • Experience of innovative technologies (eg NGS, personalized medicine, molecular diagnostics, etc) highly desirable • Previous experience in a regulatory body within target markets (US, EU, etc.) desirable/preferred • Examples of how your work has had a positive impact on and/or advanced the in vitro diagnostics industry desirable • Existing established network of decision-makers within the regulatory and in vitro diagnostic industries desirable • Previous consulting experience desirable Company Overview • RQM+ is a medical device company providing medical device and post-market surveillance services. It was founded in 2008, and is headquartered in Monroeville, Pennsylvania, USA, with a workforce of 501-1000 employees. Its website is https://www.rqmplus.com/. Apply Now Apply Now