Digital Compliance Specialist/Regulatory Affairs (Medical Devices, Pharmaceutical) - Remote
Posted on Sep 28, 2021 by Octopus Computer Associates
Digital Compliance Specialist/Regulatory Affairs Consultant (Medical Devices, Pharmaceutical) - Remote - English speaking
One of our Blue Chip Clients is urgently looking for a Digital Compliance Specialist/Regulatory Affairs Consultant
The project is based in Belgium but you can work fully remotely.
Please find some details below:
The Digital Compliance Specialist will be responsible for ensuring that product development, commercialization and maintenance of Technology and digital health solutions operate according to the customer standards, regulatory requirements and customer commitments.
Reporting into Digital Compliance Manager.
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 the customer 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.
SDLC & Asset Management
Gather and assess global regulatory changes with respect to digital health technologies and communicating changes and impact to all stakeholders.
Inform product development and commercialization strategies on global regulatory changes.
Form an overall strategy for evidence to support regulatory requirements for digital health solutions.
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.
Oversee change control related to data, network and infrastructure to ensure security is maintained.
Train the organization of change control processes and monitor adherence.
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.
- 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. Collaboration skills and the ability to build strong win/win relationships with partners are required. A results and performance driven attitude with strong sense of accountability and drive to get results is required.
Please send CV for full details and immediate interviews. We are a preferred supplier to the client.