- Develops and executes regulatory strategy for assigned projects on multi-discipline teams and interacts with regulatory authorities
- Preparation of Regulatory submissions (US and international) for in vitro diagnostic products
- Ensures compliance to US FDA Quality System Regulations and internal Quality System
- Reviews and approves product labeling and advertising/promotional material
- Participates in audits and inspections by regulatory authorities and certification/accreditation bodies
- Maintains awareness of global regulatory legislation and assesses impact of changes to the business.
- Consults and provides training related to regulations and regulatory requirements.
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas
- Minimum 4 – 6 years medical device/in vitro diagnostics regulatory and/or equivalent experience.
- Knowledge of system and software development and regulatory requirements would be beneficial.
- Experience with U.S. FDA submissions (Pre-Submissions, 510(k) and PMA) and interaction with FDA reviewers preferred
- Knowledge and experience with global registrations (including IVDR, Canada and Japan) and development of in vitro diagnostics and medical devices a plus
- Strong leadership, interpersonal, communication and organizational skills required
- Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities
- Must be able to set priorities as well as adapt to changing priorities
Job ID: 189433
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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