J&J Family of Companies Digital Compliance Manager in Beerse, Belgium
Digital Compliance Manager
Location: JnJ EMEA Location
As Digital Compliance Manager, you will be responsible for ensuring that product development, commercialization and maintenance of digital health solutions operate according to Johnson & Johnson standards, regulatory requirements and customer dedications. You will report to the Director of Quality and Regulatory Compliance and will support Product, Marketing, Operations, Science, and Commercial teams
Main Duties & Responsibilities
Product Design and Development Compliance
You will Craft the delivery framework and software development methodology to encompass the voice of all compliance partners (Regulatory Affairs, Privacy, Security, Healthcare Compliance, Legal, Medical)
Collect input and represent all areas of compliance in establishing product requirements to assure participant safety, privacy and security according to Johnson & Johnson standards, regulatory requirements and customer expectations
Provide compliance oversight and approve product deliverables intended to address participant safety, privacy and security, including compliance analyses, design and development plans, validation and verification documentation, risk analyses and design reviews.
Train the organization and partners on product compliance processes
Commercialization and Operations Compliance
Monitor on-going operations supporting digital solutions in market to assess the strength of controls for security, privacy and potential safety concerns to participants.
Maintain the procedures and work instructions to satisfy regulatory requirements for participant privacy and safety.
Define compliance requirements for Business Continuity and Disaster Recovery Planning.
Handle data retention, transfer, de-identification and disposal.
Coordinate periodic compliance auditing and monitoring.
Develop and handle follow-up monitoring plans
Establish product change control processes with appropriate approval commensurate with the level of risk and classification of the solutions.
Document inputs and outputs of the change control process and maintain change control and product history records.
Lead change control related to data, network and infrastructure to ensure security is maintained.
Train the organization of change control processes and monitor adherence
Gather and assess global regulatory changes with respect to digital health technologies and communicating changes and impact to all partners.
Inform product development and commercialization strategies on global regulatory changes.
Form an overall strategy for evidence to support regulatory requirements for digital health solutions.
Qualifications, Skills & Experience
Bachelor’s degree is required, preferably, in healthcare, science, engineering, computer science or other technical discipline.
Experience working with regulatory and compliance functions within medical device / pharmaceutical industries (highly desirable).
Understanding of medical device / pharmaceutical regulations for software from U.S. and OUS authorities (highly desirable).
Exposure to current practices for software as medical devices required, including risk analyses, verification and validation, design reviews (highly desirable)
Experience with software development practices required.
General understanding of cybersecurity standards and security compliance (highly desirable).
Extraordinary analytical and creative problem solving skills; self-starter and solution-oriented individual that can act independently and run a team
Ability to make risk-based decisions.
Ability to solve complex business problems and present recommendations to senior management effectively
Strong verbal and written communication skills
Project Management experience (Six Sigma, Lean Six Sigma, or Capability Maturity Model)
Digital and experience with SAAS, SOA, API platforms
Experience working with IT security and/or risk management organization (advantageous)
Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-Italy
Janssen Pharmaceutica N.V. (7555)