The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
- 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 8 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs or equivalent.
KNOWLEDGE, SKILLS, AND ABILITIES
- 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.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- 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