Heinz Steneberg

Experience

• MDSS USA

  President

  May 2025 - Present

  MDSS USA is a company.

  • Served as company President with full operational responsibility — set strategic direction, governance and go-to-market priorities.
  • Owned P&L, budgeting and resource allocation to support growth and sustain operations.
  • Built and led cross-functional teams (operations, regulatory, commercial) to scale service delivery and client support.
  • Established partnerships and vendor relationships to expand service offerings and market reach.
  • Implemented corporate compliance practices and oversight to align operations with applicable regulatory requirements.
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  Molecular Testing Labs

  VP of Regulatory Affairs

  May 2023 - May 2025

  Molecular Testing Labs, a partner in diagnostic care for clinicians, distributors, scientists and universities, provides accessible convenient collection kits for non-clinically collected samples.

  • Provided executive oversight of Regulatory Affairs for medical devices and diagnostics, defining regulatory strategy across US and global jurisdictions.
  • Interpreted complex diagnostics/device guidance and translated requirements into pragmatic pathways for high‑complexity diagnostic products.
  • Led regulatory interactions and submissions with US and international authorities, aligning cross-functional teams on submission content and timelines.
  • Partnered closely with R&D and scientific leadership to integrate regulatory requirements into product design, clinical plans and commercialization activities.
  • Coached and mentored regulatory staff to strengthen capabilities in diagnostic regulatory strategy and global market access.
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  Quest Diagnostics

  Executive Director, Quality Assurance & Regulatory Affairs

  Aug 2022 - Apr 2023

  The Quest Diagnostics difference. Bringing together quality, speed, and technology to power advanced, affordable diagnostics for all.

  • Acted as Management Representative responsible for implementing and maintaining the Quality Management System for Companion Diagnostics (CDx).
  • Defined clinical and regulatory strategies for CDx products, coordinating regulatory, clinical and quality stakeholders.
  • Oversaw clinical study submissions (US IDE, EU Annex XIV) and established processes for regulatory submissions, including cybersecurity and software considerations.
  • Represented Quality Management and Regulatory Affairs on the executive team and provided operational leadership to ensure product and program compliance.
  • Developed procedures and controls to support regulatory submissions, post‑market surveillance and ongoing compliance for CDx products.
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  ZEISS Medical Technology

  Head, Regulatory and Clinical Affairs

  Oct 2021 - Aug 2022

  ZEISS is an internationally leading technology enterprise operating in the fields of optics and optoelectronics.

  • Developed and executed global regulatory strategies for software‑driven ophthalmic devices to secure marketing authorizations and manage post‑approval changes.
  • Served as regulatory representative on the executive team, providing operational leadership and influencing product lifecycle decisions.
  • Led and developed a team of regulatory professionals; fostered professional development through mentoring, coaching and tailored assignments.
  • Served as the Person Responsible for Regulatory Compliance (PRRC) and led the implementation program for Medical Device Regulation (MDR) compliance.
  • Managed submissions and post‑market reporting, and coordinated regulatory input for product design, software and cybersecurity topics.
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  Roche

  Director of Regulatory Affairs

  Jul 2016 - Oct 2021

  Roche has grown into one of the world’s largest biotech companies, as well as a leading provider of in-vitro diagnostics and a global supplier of transformative innovative solutions.

  • Led Regulatory Affairs for Blood Screening and Infectious Diseases lifecycle teams with broad responsibility across development, portfolio and lifecycle management.
  • Acted as primary point of contact for FDA (CDRH & CBER), leading regulatory discussions and negotiations for INDs, BLAs, PMAs, De Novo submissions, EUAs and 510(k)s.
  • Designed and executed strategies for EU approvals (IVDD Annex IIA/IIB) and managed change notifications and certificate renewals.
  • Led notified‑body transition planning to mitigate Brexit impact and ensure business continuity in the EU, negotiating pragmatic solutions with notified bodies.
  • Served as Regulatory Lead for IVDR implementation, coordinated cross‑functional stakeholder communication, and supported advocacy through formal comments and regulator engagement.
  • Reviewed and approved scientific publications, presentations and marketing materials for regulatory compliance.
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  Grifols

  Director Regulatory Affairs

  Apr 2015 - Jul 2016

  We're a tool for connecting followers to your entire online world — not just one feed.

  • Developed regulatory strategies and managed submissions for immunology and immuno‑hematology products, ensuring compliance across product lifecycles.
  • Led and coached a team of regulatory professionals, establishing development paths and performance expectations.
  • Managed regulatory compliance activities associated with a company acquisition, including oversight of the US Biologics License change process.
  • Established internal processes and controls to support consistent review and regulatory decision‑making across the product portfolio.
  • Collaborated with cross‑functional teams (quality, manufacturing, legal) to align regulatory requirements with business objectives.
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  Abbott Diabetes Care

  Director, Regulatory Affairs

  Apr 2011 - Apr 2015

  Abbott's life-changing technology helps people live fully and offers information, medicines and breakthroughs to help you manage your health.

  • Developed and executed international regulatory strategies for blood glucose monitoring strips and glucose meters across APAC, LATAM and North America.
  • Managed regulatory submissions and post‑approval supplements in multiple jurisdictions (Australia, Brazil, Canada, China, Japan, Singapore, South Korea).
  • Prioritized resource planning and capacity management to meet global submission timelines and sustaining requirements.
  • Built and developed regulatory team capabilities to support ongoing registration activities and country‑specific requirements.
  • Coordinated with local regulatory authorities and notified bodies to maintain approvals and support market access.
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  Medtronic Spinal & Biologics (formerly Kyphon)

  Senior Regulatory Affairs Program Manager

  Sep 2007 - Apr 2011

  A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.

  • Managed Regulatory Affairs for Interspinous Process Decompression Systems (spinal implants) including US PMA, PMA‑S and IDE submissions and international filings.
  • Planned and executed regulatory strategies for approvals and sustaining activities across China, ASEAN, Japan, Europe and Canada.
  • Led regulatory and cross‑functional teams through product lifecycle activities including post‑approval study reports, annual reports and design/process changes.
  • Provided coaching and training to regulatory staff, building capability and improving team performance.
  • Served as primary regulatory liaison for internal stakeholders to ensure timely, compliant global market access.
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  St. Jude Medical CRMD

  Director, Intl. Regulatory Submissions

  Oct 2006 - Jul 2007

  Abbott develops life-changing medical devices for cardiovascular conditions.

  • Led a global team of regulatory professionals to achieve timely approvals for implantable cardioverter defibrillators (ICDs) and implantable pacemakers.
  • Spearheaded regulatory process improvements and cross‑functional initiatives to strengthen the risk management system.
  • Coordinated global submission strategies and interactions with regulators to minimize approval timelines and post‑market obligations.
  • Implemented procedures to improve regulatory documentation quality and consistency across product families.
  • Collaborated with clinical, engineering and quality groups to align development plans with regulatory expectations for implantable devices.
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  Medtronic Vascular

  RA Manager

  Jan 2004 - Oct 2006

  • Represented Regulatory Affairs on the core cross‑functional team for development of a drug‑eluting stent and led the marketing authorization strategy.
  • Prepared and managed regulatory submissions that secured timely market approvals and supported clinical IDE filings and supplements.
  • Coordinated regulatory input for design changes, manufacturing updates and supporting clinical evidence during product development.
  • Collaborated closely with clinical, R&D and manufacturing teams to ensure regulatory expectations were met throughout development and commercialization.
  • Supported post‑submission activities including responses to authorities and management of regulatory commitments.
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  TUV Rheinland of North America

  Division Manager, Medical Division

  Apr 2002 - Dec 2003

  TÜV Rheinland is a world leader in testing, inspection and certification services for a wide variety of industries. As a global technical service provider with over a century of experience, TÜV Rheinland’s guiding principle is to achieve sustained development of safety and quality in order to meet the challenges arising from the interaction between man, technology and the environment.

  • Directed full P&L and budgetary responsibility for the Medical Division, delivering significant growth and turning the division profitable.
  • Secured key accreditations: CMDCAS (Canadian Medical Device Conformity Assessment System) and FDA Third‑Party Accredited Person (AP) Inspection Program.
  • Established and maintained quality system procedures to support medical conformity assessment and regulatory services.
  • Designed and delivered seminar programs and training; served as frequent presenter at RAPS and industry events to build thought leadership and business development.
  • Negotiated technical and commercial arrangements with clients and oversaw certification and surveillance activities.
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  TUV Rheinland of North America

  Technical Manager/Program Manager

  Jun 1999 - May 2001

  • Directed technical review of 510(k) submissions under the FDA Third‑Party Review program to support timely market access for medical devices.
  • Oversaw review of Design Dossiers and Technical Files for EU Medical Device Directive conformity assessment projects.
  • Established and maintained quality system procedures to ensure consistent, auditable assessment processes.
  • Negotiated technical and regulatory issues with clients and provided regulatory strategy guidance.
  • Planned and performed certification and surveillance audits to the EU Medical Device Directive and ISO 13485, ensuring compliance and readiness for regulatory inspections.