POSITION SUMMARY:

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.   

PRIMARY RESPONSIBILITIES:

• 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 U.S. regulatory agencies.

• Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.

• Participates in the development and review of product release documents.

• 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 premarket 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.

• Must maintain a current status on Natera training requirements.

QUALIFICATIONS:

• Bachelor's degree or equivalent; degree in biological sciences, chemistry, or related science strongly preferred.

• Minimum 5 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) 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.