Digital Compliance & Regulatory Affairs Specialist

Applied Medical•Lebanon, PA

About The Position

Applied Medical is a rapidly growing, global organization that develops, manufactures, and distributes medical devices to more than 75 countries. Our driving purpose is to satisfy the three fundamental healthcare needs: enhanced clinical outcomes, outstanding value, and unrestricted choice. For 30 years, Applied Medical has been at the forefront of innovation and technology. As a result of our highly vertically integrated business model, we control all our processes in-house, from R&D concept to clinical implementation. At our state-of-the-art manufacturing plants in the US and The Netherlands, we develop advanced surgical technologies for minimum invasive surgery. For over 30 years, Applied Medical has earned a strong reputation in healthcare as a leading provider of advanced medical devices. At our Middle East headquarters, we support the implementation of our innovative products across the MENAT region through our local sales teams and via our distributors. What connects us all is our mission to improve the quality and affordability of healthcare by enhancing patient outcomes through innovative design and exceptional product quality. If you would like to be part of an innovative and rapidly growing international organization that makes decisions based upon what is right for the patient, customer, community, and environment, then Applied Medical is the place for you! The Digital Compliance & Regulatory Affairs Specialist is responsible to support the development, implementation, and ongoing maintenance of the organization’s technology regulatory intelligence and compliance management process. As well as, monitoring, interpreting, assessing, and supporting the implementation of regulatory requirements related to artificial intelligence (AI), digital technologies, software systems, data governance, cybersecurity, privacy, and other emerging technologies. The position translates regulatory developments into clear business requirements and supports cross-functional readiness, governance, and ongoing compliance across different jurisdictions.

Requirements

Strong analytical, research, problem-solving, and writing skills, with the ability to interpret complex regulatory requirements, assess their impact, and communicate findings clearly.
Ability to support the development of policies, procedures, compliance frameworks, and regulatory intelligence reports.
Strong organizational and project management skills, with the ability to manage multiple initiatives and changing priorities simultaneously.
Ability to work independently, exercise sound judgment, and maintain confidentiality when handling sensitive compliance matters.
Ability to collaborate effectively with technical and non-technical stakeholders.
Excellent written and verbal communication skills in English.
Proficiency in Microsoft 365 tools and the use of structured trackers and documentation tools.
Bachelor’s degree in law, regulatory affairs, information technology, information systems, or a related field.
Minimum of 2 years’ experience in regulatory compliance, technology compliance, AI governance, regulatory intelligence, data privacy, cybersecurity, risk management, or a related field.

Nice To Haves

Working knowledge of AI governance, data protection, cybersecurity, digital regulation, and technology risk concepts is a plus.
Experience in a regulated, international, technology-enabled, healthcare, or medical device environment is preferred.

Responsibilities

Support the development, implementation, and maintenance of regulatory intelligence, compliance, and digital governance programs.
Monitor and track new and emerging regulations, standards, guidance documents, and industry trends related to digital technologies, artificial intelligence, cybersecurity, data privacy, data governance, and regulatory affairs.
Maintain a centralized register of applicable regulatory requirements, regulatory updates, assessments, ownership, actions, and implementation status.
Conduct preliminary reviews and impact assessments of new or changing global regulatory requirements and identify affected processes, systems, or business operations.
Maintain traceability between regulatory requirements, organizational processes, systems, and policies
Support the preparation of regulatory intelligence reports and dashboards.
Assist in developing and maintaining compliance documentation, process maps, and compliance trackers
Identify compliance gaps, document findings, and support remediation and continuous improvement efforts.
Stay informed of industry developments and continuously build knowledge in regulatory affairs, compliance, digital technologies, and governance practices.
Participate in cross-functional projects that support organizational compliance, operational readiness, and regulatory risk management.
Support governance forums and cross-functional discussions concerning AI and emerging technology risks.
Support maintaining compliance checklists and assess tools for applicable technology regulations.
Communicate regulatory developments in a timely and accessible manner to impacted stakeholders.
Monitor regularly regulatory developments, conducting research, preparing assessments, and participating in cross-functional meetings and projects.
Support occasionally meetings and regulatory activities across different time zones.
Handle sensitive and confidential information with a high degree of professionalism, integrity, and discretion.