About the Job

The Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI’s unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including registration of new products and regulatory activities for on-market products across the globe. This role will also be responsible for other key projects within Regulatory Affairs, as applicable. This role requires creative and strategic thinking and excellent communication skills and partners closely with cross-functional stakeholders in Commercial, BioPharma, Operations, R&D, and Technology. As a member of the RA leadership team, this role contributes to the overall development and delivery of the department strategy and vision, provides insights for decision-making, and leads or sponsors department-wide and cross-functional projects.

Key Responsibilities

• Develop and drive international regulatory strategy covering FMI’s assay products, specimen collection kits, software, and laboratory operations:
  • Lead cross-functional initiatives to improve regulatory strategy of international product registrations.
  • Develop and implement international regulatory strategy to address IVD regulations in EU and Ex-US countries for IVD, CTA, and CDx submissions.
  • Identify innovative and novel regulatory approaches to software, data and digital products; new assay and biomarker product launches and major platform updates; mature assay products and minor on-market product changes; CTA, and companion diagnostic submissions and approvals across all products.
  • Provide regulatory guidance and strategy pertaining to product development.
  • Influence regulatory strategy both within the organization as well as externally with pharmaceutical partners.
  • Lead other key projects, as applicable.
• Drive Cross-Functional Collaboration and Strategies:
  • Establish strong partnerships and relationships with internal stakeholders across the Roche enterprise.
  • Ensure proactive and effective communication across the organization.
  • Strategically represent Regulatory Affairs on cross-FMI and cross-Roche initiatives.
  • Partner with cross-functional colleagues to continuously drive improvement and innovation across products and processes.
  • Recognize and act upon value-generating opportunities in the context of new and existing collaborations by bringing together a team of internal stakeholders.
  • Contribute as a thought-partner for innovative global strategy.
• External Relationship Management:
  • Establish strong partnerships and relationships with external stakeholders.
  • Ensure proactive and effective communication with external partners.
  • Leverage understanding of partner’s structure, people, strategy, and communication style and processes to inform decisions.
  • Creatively approach challenges and problem resolution to optimize submission strategies with international regulatory bodies Influence regulatory policy with regulatory bodies and industry consortia.
• Maintain Knowledge of Evolving Regulatory Landscape:
  • Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on Regulatory Affairs projects and make modifications as necessary.
  • Maintain knowledge of current IVD and device regulations and guidelines and company policies, SOPs and procedures.
• Other duties pertinent to Regulatory Affairs as occasionally assigned.

Qualifications:

Basic Qualifications:

• Bachelor’s Degree and 12+ years of demonstrated experience in device or digital product, pharmaceutical/biologics regulatory, or scientific discipline including at least 5 years of demonstrated experience specifically in regulatory affairs; OR 
• Advanced Degree in science, law, health policy, regulatory affairs or engineering and 8+ years of demonstrated experience in device, pharmaceutical/biologics regulatory, or scientific discipline including at least 3 years of demonstrated experience specifically in regulatory affairs work

Preferred Qualifications:

• Masters or Advanced Degree in a science, law, health policy, regulatory affairs or engineering discipline
• 12+ years of professional work experience in a molecular testing laboratory, diagnostic manufacturing organization and/or a diagnostics service organization
• 6+ years working in a regulatory affairs department executing or overseeing regulatory submissions
• Experience engaging in direct negotiations with the FDA, PDMA, EMA, Notified Bodies, or other regulatory bodies 
• Experience preparing and submitting successful global marketing authorization applications 
• An understanding of the multiple routes to clearance or approval of a diagnostic product
• Ability to influence and negotiate effective solutions through leading change and driving for results
• Strong analytical skills and ability to apply strategic-thinking and problem-solving skills to meet business objectives
• Outstanding presentation and communication skills
• Strong history of achievement demonstrated by leadership activities, publications, presentations or other activities 
• Collaboration skills and the ability to effectively communicate (written and oral) with internal and external team members on project activities 
• Highly effective teamwork and collaboration skills
• History of leadership and track record of applying strategic and system thinking
• Proven history of successful global regulatory registrations and approvals for IVD products
• Understanding of HIPAA, GDPR and importance of patient safety and data privacy regulations and guidelines 
• Commitment to FMI’s values: innovation, patients, collaboration, and passion

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