- The Regulatory Affairs will support project execution activities as part of configuration and implementation of an internal Regulatory submissions system.
- Will work with various functional teams (Business Unit Regulatory Affairs, Division Regulatory Affairs, IT) on creation and compilation of regulatory assessment checklists, submission content plan templates, development of regulatory process procedures and guides and evaluation and verification of product master data for our medical and in vitro diagnostic devices.
Essential Duties and Responsibilities (Key Activities):
- Applies regulatory and technical knowledge to a wide variety of complex work assignments.
- Carries out duties in compliance with established business policies and procedures.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
- Assist Business Project Lead in other daily activities related to business activities needed to support internal Regulatory submissions system configuration and implementation.
- Lead the regulatory assessment checklists, submission content plan templates, evaluation and verification of product master data. Will require collaboration with various functions.
- Collaborate, communicate, and provide status to key stakeholders.
- Maintain ability to comply with business continuity plan (i.e. Work remotely)
- Support writing procedures and other documents supporting the internal Regulatory submissions system
- Other duties as assigned
Dimensions – Education / Experience / Skills:
- Bachelor’s degree (BS) in a relevant discipline i.e. engineering, data sciences, computer sciences or analytics.
- Minimum 3 years of experience in Medical Device/IVD Regulatory Affairs
- Experience in Medical Device/In Vitro Diagnostics (IVD) regulatory submissions
- Experience in Medical Device/In Vitro Diagnostics (IVD) regulatory change assessment
- Must demonstrate the application of advanced problem-solving methodologies, be detail-oriented, a critical-thinker, and experienced at investigating and resolving complex issues
- Must be computer literate; proficient in MS Word, PowerPoint, Excel, and Outlook
- Must have strong written and verbal communication skills
- Must have the ability to take ownership, organize workload and change priorities quickly
- Must be able to assume responsibility and accountability for daily tasks and highlight any risks to the Supervisor
- Must have ability to maintain focus and drive to deliver results on committed timelines
- International exposure and experience, operating across multiple time zones