- 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
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.