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oracle

Senior Knowledge Specialist, GMA

UL Solutions
USA
Senior · 5–7 years experience
Onsite
USD 90000-110000 / year
Discovered Today
Communication

Full Job Posting

Qualifications

  • Bachelor's Degree required.
  • Minimum 5-7 years of relevant experience.
  • Excellent working knowledge of the TIC business and the industries in which the business functions. Independently able to connect the regulation rules with customer needs and Business opportunities.
  • Natural influencing skills, confidence and be able to deliver the message.
  • Good planning, organization and project management skills. Earlier program management experience preferred.
  • Able to deal in the ambiguity and take decisions, support customers in understanding their problem and provide valid solutions based on knowledge of schemes and past experiences.
  • Experienced and knowledgeable for one or multiple geographic area, multiple areas of regulations and lead business decisions from COUs and other team members.
  • Strong customer focus and solution-oriented mindset.
  • Excellent in communication, able to summarize requirements and describe with easy word difficult concept, network builder.
  • Excellent written and verbal communication skills in English.
  • Bachelor’s Degree Engineering, Biomedical Engineering, Computer Science / Software Engineering, Medical Device Cybersecurity or Information Security or other specialization based on the specific coverage.
  • What We Offer:
  • Total Rewards: We understand compensation is an important factor as you consider the next step in your career. The estimated salary range for this position is $90,000-$110,000 USD and is based on multiple factors, including job-related knowledge/skills, experience, geographical location, as well as other factors. This position is eligible for annual bonus compensation with a target payout of 10% of the base salary.
  • This position also provides health benefits such as medical, dental and vision; wellness benefits such as mental and financial health; and retirement savings (401K) commensurate with the standard rewards offered in each individual location or country. We also provide full-time employees with paid time off including vacation (15 days), holiday and personal days (totaling 12 days) and sick time off (72 hours).
  • #LI-MK2
  • #LI-Hybrid

Responsibilities

  • Demonstrate the ability to complete core daily tasks cross multiple regulations, countries, such as:
  • Publishing high-quality news and delivering accurate and valuable research report with a high level of quality and within required timelines
  • Maintaining data
  • Updating relevant internal files trackers and related resources
  • Develop and deliver internal and external training programs on medical cybersecurity requirements.
  • Provide mentorship, coaching, and technical guidance to team members.
  • Monitor and research global medical device cybersecurity regulations, guidance documents, standards, and industry best practices.
  • Analyze regulatory frameworks such as:
  • FDA Cybersecurity Requirements for Medical Devices
  • EU Medical Device Regulation (MDR) cybersecurity expectations
  • ISO 14971 cybersecurity considerations
  • Cyber Resilience Act (CRA)
  • NIS2 Directive
  • AI Act cybersecurity requirements
  • FDA Premarket & Postmarket Cybersecurity Guidance
  • IMDRF Cybersecurity Frameworks
  • Health software and Software as a Medical Device (SaMD) requirements, etc.
  • Explain regulatory requirements, certification pathways, and compliance expectations to customers and internal COUs and stakeholders.
  • Collaborate with business development teams to identify knowledge service opportunities and support customer proposals.
  • Assist in developing customized regulatory intelligence services and subscription offerings.
  • Contribute to strategic expansion areas including cybersecurity, AI, data governance, and emerging technology regulations.
  • Maintain accurate, current, and traceable regulatory content within GMA knowledge tools and databases.
  • Develop executive summaries, impact assessments, and regulatory comparison reports.
  • Provide point-of-access support to address any local acceptance issues under supervision and guidance.
  • Support the CO team in identifying and investigating business opportunities related to emerging cybersecurity, data governance, and AI regulations.
  • Read and follow the Underwriters Laboratories Code of Conduct, and follow all physical and digital security practices.
  • Perform other duties as directed.

Preferred Qualifications

  • Good planning, organization and project management skills. Earlier program management experience preferred.

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