IVDR Regulatory Affairs Consultant
Our client, a leader in medical devices, is seeking a IVDR Regulatory Consultant.
This position will support a project to prepare the Toxicology Business Unit for conformity to EU In Vitro Diagnostic Medical Device Regulation (IVDR).
- Collaborate with Program Managers and other departments to determine action items and deliverables to address gaps in quality system(s) and product files.
- Assist with program management of deliverables per project plan, if needed.
- Assist with the creation/revision of IVDR procedures, forms and templates.
- Initiate and route change orders to implement procedures at toxicology sites.
- Assist with the implementation of new tech file template at toxicology sites.
- Review and approve deliverables for technical files, such as verification and validation testing protocols and reports, post marketing surveillance reports, risk
- Write technical files per IVDR requirements and route for review and approval.
- Correspond with Notified Bodies to obtain certifications.
- Correspond with EU Authorized Representative for product registrations and EUDAMED updates
- Track and report status of regulatory affairs deliverables to management.
- Other tasks may be assigned of a regulatory affairs nature, as needed
- Excellent organizational skills (must keep track of status of many moving pieces at the same time)
- Good work ethic; ability to work independently (expectation that work will be completed on time with minimal supervision)
- Good attention to detail
- Ability to read, understand, and summarize technical and scientific information
- Ability to interpret and apply regulations to company policies and procedures
- Advanced user in Microsoft WORD, Excel and PowerPoint, and Adobe Acrobat DC or Pro
- Proficient with electronic document management systems
Experience and Education:
- B.S. or B.A. in a scientific or technical discipline
- 5+ years’ experience in Regulatory Affairs or Quality Assurance for medical device and/or in vitro diagnostic device manufacturer
- Prior experience managing EU technical files and/or international registrations
- Prior experience participating on product development teams
- Prior experience reviewing and approving design control documentation, such as verification and validation testing protocols and reports, risk management reports, scientific validity reports, and product labeling
- Understanding of the requirements in the current EU IVD Directive and new EU IVD Regulation
- Prior experience authoring standard operating procedures, forms and templates
- Candidate will need to spend several days consecutively at a time on location at Toxicology manufacturing sites to receive training, collaborate with other departments, or manage deliverables.
- On-site presence will be more frequent early in the project and can reduce in frequency as the candidate establishes themselves.
- Candidate should expect to spend at least 2 weeks on site during the first month.
- All travel expenses including airfare, hotel, meals, rental car, and gas will be paid for by the employer.