at APN Software Services Inc. in Newark, Delaware, United States
Work location can be Newark, DE or Tarrytown, NY. Due to the pandemic, the position will initially be remote until we can return to the office.
Manager looking for 2-5 years experience
Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017/746) by performing the following:
• Create and review technical documentation for reagents, calibrators, controls, and other in vitro diagnostic products to comply with European In Vitro Diagnostic Regulation (2017/746/EU).
• Gather regulatory documents and information to support creation of technical documentation.
• Identify and close gaps in technical documentation.
• Work collaboratively to complete tasks, both within regulatory affairs and with other departments.
• Create, review, and route for approval EU Declarations of Conformity.
• Provide periodic progress reports to supervisors.
• Attend in-person and teleconference meetings as assigned.
• Prepare finished IVDR technical documentation for submission to the Notified Body.
• Prepare quality records for electronic archival.
• Education: Bachelor of Art/Science in a Science related field.
• Regulatory Affairs experience in an industry such as pharmaceuticals, medical devices, or in vitro diagnostics.
• Proficiency with Windows and Microsoft Office (especially Microsoft Word and Excel).
• Great time management and organizational skills.
• Experience with and knowledge of (a) the European In Vitro Diagnostics Medical Devices Directive (IVDD 98/79/EC) and/or (b) the European In Vitro Diagnostic Regulation (IVDR 2017/746).
• Experience with SAP.
• Experience with medical device labeling review.
• Regulatory Affairs experience with in vitro diagnostics.
• Proficiency with Windows 10 and Microsoft Office 365.
As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.