Digital Compliance Specialist
Are you up for a new challenge? Your IT skills and knowledge are needed for a renowned Biotech company in Beerse.
As a Digital Compliance Specialist, you will be responsible for ensuring that product development, commercialization and maintenance of Technology and digital health solutions operate according to standards, regulatory requirements and customer commitments.
Product Design and Technology Development Compliance
- Shape the delivery framework and Technology development methodology to encompass the voice of all compliance stakeholders (Regulatory Affairs, Privacy, Security, Healthcare Compliance, Legal, Medical, external regulatory bodies)
- Collect input and represent all areas of compliance in establishing product requirements to assure participant safety, privacy and security according to 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.
Oversee data retention, transfer, de-identification and disposal.
- Coordinate auditing and monitoring, including periodic, internal security audits and routine scanning.
- Develop and oversee follow-up monitoring plans.
Required Knowledge, Skills and Abilities:
- Experience working with regulatory and compliance functions within medical device / pharmaceutical industries strongly preferred.
- Understanding of medical device / pharmaceutical regulations for software from U.S. and OUS authorities required.
- Exposure to current practices for software as medical devices required, including risk analyses, verification and validation, design reviews
- Experience with software development practices required.
General understanding of cybersecurity standards and security compliance required.
- Background in digital compliance and at least 5 years professional experience.
- Exceptional 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.
- Ability to function as part of a broader organizational team is also required.
- Big picture orientation with strong attention to detail is required.
Start date: ASAP
Duration: 1 year (possibility of extension)
Please apply with CV. For further information, please contact Ernest Banor on +31(0)20 20 44 502 or by email firstname.lastname@example.org