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Mdr Consulting Jobs in Utah (NOW HIRING)

Telarus

Solution Architect - Security

Sandy, UT · On-site

$150K - $180K/yr

WHY THIS ROLE EXISTS Security is a fast-moving, consultative product - and it is the one where end ... MDR, email and collaboration security, data protection and DLP, cloud posture (CSPM/CNAPP), OT/IoT ...

Telarus

Solution Architect - Security

Sandy, UT

WHY THIS ROLE EXISTS Security is a fast-moving, consultative product - and it is the one where end ... MDR, email and collaboration security, data protection and DLP, cloud posture (CSPM/CNAPP), OT/IoT ...

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Mdr Consulting information

What is the difference between Mdr Consulting vs Business Analyst?

AspectMdr ConsultingBusiness Analyst
Required CredentialsRelevant certifications (e.g., PMP, Agile), industry experienceCertifications like CBAP, PMI-PBA, and similar experience
Work EnvironmentConsulting firms, client sites, project-based settingsCorporate offices, project teams, cross-functional departments
Employer & Industry UsageConsulting companies, IT, finance, healthcare sectorsCorporations, government agencies, tech firms
Common Search & ComparisonOften compared for project roles, client-facing workCompared for process analysis, requirements gathering

While both roles involve analysis and project work, Mdr Consulting typically refers to consulting firms providing specialized services across industries, often requiring certifications and client engagement. Business Analysts focus on internal process improvements within organizations, emphasizing requirements gathering and analysis. The roles overlap in skills but differ mainly in work setting and scope.

What are the key skills and qualifications needed to thrive as an MDR consultant?

To thrive as an MDR Consultant, you need expertise in cybersecurity, threat detection, incident response, and a solid understanding of network and endpoint security, typically supported by a degree in computer science or information security. Familiarity with SIEM platforms, EDR tools, and industry certifications like CISSP or CEH is highly valued. Strong analytical thinking, problem-solving abilities, and effective communication skills help you interpret threats and advise clients. These competencies are vital to proactively protect organizations, respond to security incidents, and build client trust in a rapidly evolving threat landscape.

What is MDR consulting?

MDR consulting refers to expert advisory services that help medical device companies comply with the European Union Medical Device Regulation (EU MDR). These consultants assist businesses in understanding regulatory requirements, preparing technical documentation, conducting gap analyses, and ensuring products meet safety and performance standards for market approval in the EU. MDR consultants are especially valuable for navigating complex regulatory processes and maintaining compliance as regulations evolve.

What are some common challenges faced by MDR consultants, and how can they be addressed?

MDR Consultants often face the challenge of staying current with rapidly evolving cyber threats while managing multiple client environments with diverse security needs. Balancing proactive threat hunting with reactive incident response can be demanding, requiring strong time management and prioritization skills. Building effective communication with client IT teams is essential to ensure timely implementation of security recommendations. Continuous professional development and collaboration with peers help MDR Consultants maintain expertise and deliver high-value services.

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Mdr Consulting jobs near you

Director, Regulatory Affairs & Quality Systems

Xenter

Draper, UT • On-site

$150 - $200/hr

Other

Posted 9 days ago

Job description

Director, Regulatory Affairs & Quality Systems About Xenter

Xenter is a technology in medicine company that is bringing medical devices to the digital age. Xenter is revolutionizing medicine by developing and launch ing diagnostics at the point of care sm art/wireless guidewires and catheters that transmit data through a proprietary wireless network to our proprietary cloud that collects and houses real-time Physical Intelligence medical data.

Position Summary

The Vice President of Regulatory Affairs & Quality Systems will serve as Xenter's senior leader accountable for the full RA/QA function. Reporting to the CEO, this executive will set global regulatory strategy, own the quality management infrastructure, and build the organizational capability needed to scale from a development-stage company through commercialization and public company readiness. The VP will be a key voice at the leadership table, partnering with R&D, Digital, Clinical, Commercial, and Finance leaders to enable compliant, timely product launches and investor-ready governance.

Key Responsibilities Regulatory Strategy & Leadership
  • Set and own global regulatory strategy across the full product portfolio, including digital cloud/AI tools, diagnostic, Class II and emerging Class III pathways.
  • Lead regulatory submissions (510(k), IDE, PMA, De Novo) and all agency interactions, including FDA meetings and correspondence.
  • Provide regulatory counsel to the executive team on product strategy, clinical design, and commercialization planning.
  • Anticipate the regulatory environment—tracking FDA guidance, policy changes, and international developments—and position Xenter proactively.
  • Represent Xenter in interactions with regulatory bodies, notified bodies, and external partners.
Quality Systems Oversight
  • Own the design, implementation, and continuous improvement of a scalable QMS compliant with 21 CFR Part 820 and ISO 13485.
  • Establish and govern CAPA, complaint handling, MDR, post-market surveillance, supplier quality, and audit programs.
  • Ensure design control integrity (DHF, DMR, DHR) and risk management alignment with ISO 14971 across the product lifecycle.
  • Drive quality culture and accountability across the organization.
Inspection & Audit Readiness
  • Serve as the executive leader responsible for FDA inspection readiness and outcomes.
  • Lead preparation of the organization, including executive leadership and the Board, for agency interactions.
  • Oversee ISO 13485 certification, surveillance audits, and remediation programs.
Pre-IPO & Investor Readiness
  • Build RA/QA infrastructure and documentation that withstands public company scrutiny and investor due diligence.
  • Develop KPIs, risk frameworks, and board-level reporting for regulatory and quality performance.
  • Serve as subject matter authority in financing, M&A, and partnership transactions.
Organizational Leadership
  • Build, mentor, and scale the RA/QA team, including direct hires, contractors, and consulting partners.
  • Establish the operating model, budget, and talent strategy for the function.
  • Model a culture of quality, compliance, and operational excellence across Xenter.
Qualifications Required
  • Bachelor's degree in life sciences, engineering, information security or related field; advanced degree strongly preferred.
  • 15+ years of progressive regulatory affairs and quality systems experience in medical devices and software.
  • Demonstrated track record leading FDA submissions and agency interactions at a senior level.
  • Extensive knowledge of 21 CFR Part 820, ISO 13485, and applicable global regulatory frameworks.
  • Experience with Class II and/or Class III device submissions, including complex or novel technologies.
  • Proven ability to lead and scale RA/QA functions in a growth-stage environment.
  • Executive presence and experience presenting to boards, investors, and senior leadership.
Preferred
  • Experience guiding a company through an IPO or significant capital raise.
  • Global regulatory experience (EU MDR, Canada, Japan, or APAC).
  • Experience with software-enabled, connected, or digital health medical devices.
  • RAC certification (Regulatory Affairs Certified) or equivalent credential.
  • ASQ Certified Quality Auditor (CQA) or Quality Manager (CQM).
  • Experience implementing enterprise quality management systems (eQMS).
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