Regulatory Affairs Specialist II - International
The Regulatory Affairs Specialist II will be part of the Regulatory Affairs team reporting to the Head of Regulatory and Quality. This position will perform international product registrations and act as the company representative with the applicable regulatory authorities, primarily responsible for China, Canada, and EMEA (Europe, Middle East, and Africa). The Regulatory Affairs Specialist II position will work with project teams to implement international regulatory affairs strategies with the goal of ensuring timely product marketing authorizations. The Regulatory Affairs Specialist II will create labeling and review marketing materials for regulatory compliance. Additionally, the position will support Quality System compliance, including writing and revising relevant procedures, reviewing design documents, filing post-market surveillance reports and implementing compliance mechanisms for new regulations and regulatory guidance. The Regulatory Affairs Specialist II will work to ensure all information and data in support of marketing authorizations and post market reports is complete and accurate. This position will collaborate with personnel in multiple departments to understand the products and maintain/implement new procedures and processes.
- Perform international regulatory intelligence activities for new products and post market changes in order to identify and assess regulatory risk; then provide advice and strategy to functional and product teams on international regulatory environment.
- Perform regulatory intelligence activities to keep current on the international regulatory requirements.
- Represent Regulatory on assigned project teams.
- Plan milestones and deliverables for assigned regulatory applications and renewals.
- Review supporting documentation for regulatory applications and renewals for acceptability of data, procedures, and other documentation to ensure regulatory arguments are presented clearly and conclusions are supported by data and their associated risk assessments.
- Create regulatory submissions for international regulatory applications and renewal for internal review and submission, including License Applications, Submissions, Design Dossiers, and Technical Files.
- Ensure that marketing applications and post market documentation comply with governing rules and regulations for the products.
- Work with internal personnel to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
- Interact and communicate with regulatory authorities about marketing applications, renewals, and post market reports.
- Advise and manage regulatory consultants.
- Ensure appropriate reporting of post-market events and incidents.
- Participate in the development of Regulatory department SOPs.
- Work with internal teams to ensure compliance with international regulations including designing and implementing training on regulatory issues and landscape.
- Other duties as assigned.
- Bachelor of Science in chemistry, microbiology, or related field. Master’s degree preferred.
- Five to eight years of IVD industry experience required
- Five years of regulatory experience in international markets
- Strong knowledge of Antimicrobial Susceptibility Testing desired
- Must demonstrate understanding of IVD development and post market operations
- Direct experience with NMPA required and EU competent authorities, Health Canada, and FDA experience preferred.
- Mandarin fluency, desirable
- Highly organized with attention to detail
- Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills
- Working knowledge of electronic publishing/file management system
- Familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications
- Exceptional self-management ability
- Travel as needed for interactions with international Regulatory Authorities. Extended in-country durations may be required for NMPA registrations and renewals