Regulatory Affairs Specialist
- Understands and interprets U.S. and international medical device and in vitro diagnostic device (IVD) regulatory requirements.
- Provides guidance on requirements to product development teams.
- Develops strategies for submissions to FDA and other regulatory agencies.
- Provides risk assessments and regulatory options.
- Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements.
- Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S.
- Interacts and negotiates with the U.S. and international regulatory agencies.
- Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.
- Reviews clinical protocols to assure collection of appropriate data for regulatory submissions.
- Periodically monitors status of clinical studies and reviews analysis of resultant clinical study data. Based on these data and considering the regulatory requirements, recommends appropriate courses of action. Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies.
- Provides regulatory opinions on pre-market regulatory requirements, export, and labeling requirements.
- This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job.
- Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
- Employee must pass post-offer criminal background check.
- Bachelor’s degree or equivalent; degree in biological sciences, chemistry, or related science strongly preferred.
- Minimum 2 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs or equivalent.
Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) , and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards.
- Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
- Ability to organize work, project management experience desirable.
- Duties are typically performed in an office setting.
- The position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
- Duties may require working outside normal working hours (evenings and weekends) at times.
- No ☐ or Yes ☒ : If yes state anticipated percent for travel: up to 10%
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
Job posted: 2020-06-16