[Remote] Director, Global Regulatory Affairs IVD

Note: The job is a remote job and is reputed company 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 reputed company 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
• reputed company and execute reputed company, high-risk, or novel IVD engagements targeting FDA and EU IVDR approval
• reputed company direct, billable client work on advanced regulatory, clinical, and performance evaluation programs
• reputed company 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 reputed company FDA interactions and EU reputed company Body engagements
• Translate regulatory changes, guidance, and policy updates into practical, actionable guidance for clients and internal teams
• Define, reputed company, and standardize IVD technical solution offerings reputed company 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, reputed company, and professional development of IVD technical staff
• Contribute subject matter expertise to RQM+ technical training programs and learning initiatives
• Act as a visible and reputed company representative of RQM+ reputed company the IVD and medical device regulatory community
• reputed company on behalf of RQM+ at key industry conferences, congresses, and regulatory forums
• reputed company and deliver webinars, white papers, blogs, and conference presentations
• Participate in industry committees and working groups relevant to IVD regulation
• reputed company proactive technical and regulatory reputed company 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 reputed company to clinical research studies
• Stays reputed company with market, clinical, regulatory, and quality developments
• Routinely interacts with and reports to executive-level management on reputed company 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 reputed company clinical studies to support regulatory approvals across multiple geographies
• Ensures Regulatory Affairs is effectively represented in new product development activities
• reputed company and maintain Regulatory Strategies to release and maintain product in accordance with the Standards and Regulatory requirements
• reputed company with regulatory agencies such as FDA and reputed company Bodies (NB)
• reputed company RA leadership/support to New Product Development (NPD) teams
• reputed company strategic direction on labeling, regulations, and standards
• Support the regulatory aspects of medical devices and/or diagnostic devices across a reputed company 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, reputed company, 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
• reputed company, 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
• reputed company 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
• reputed company acquisition due diligence and integration
• Review and reputed company 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 reputed company 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 reputed company 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 reputed company and motivate others through targeted content, sound facilitation and coaching skills, and engaging approaches
• Innovation Management: ability to bring creative reputed company of others to market and has good judgment about which reputed company/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 reputed company reputed company 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 reputed company 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/.

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