FDA Regulatory Affairs Professional

JOB SUMMARY:

The FDA Regulatory Affairs Professional will be part of the Legal team, and will be responsible for supporting the VP, Lead Regulatory Counsel in providing regulatory expertise and guidance in support of the US FDA regulatory needs in alignment with business objectives.  The FDA Regulatory Affairs Professional will be primarily responsible for preparation of the company’s US regulatory product submissions required to evaluate and market new or modified medical devices.  In addition, the individual in this position will play an important role in developing regulatory infrastructure and documentation templates to support regulatory processes.

This is a full time, exempt position that reports to the Vice President, Lead Regulatory Counsel.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Be an integral member of the Lead Regulatory Counsel’s team, which is broadly responsible for providing the business with strategic advice and counsel on regulatory issues and providing the Global Regulatory Affairs function with US FDA regulatory expertise in support of obtaining and maintaining regulatory approvals
• Under the direction of the Lead Regulatory Counsel, liaise with other business functions as needed (Clinical, Medical Affairs, Quality Assurance, Clinical Operations, Marketing) to provide regulatory affairs and regulatory sciences guidance throughout the product development cycle
• Hands on drafting and review of US FDA filings for the company’s commercial devices and investigational devices under clinical study, including pre-submissions and postmarket approval reports
• Provide regulatory-based scientific and statistical input in the planning and design of clinical studies (including feasibility studies), premarket clinical studies and postmarket studies in support of US FDA marketing applications
• Help facilitate cross-functional team inputs for regulatory submissions
• Support the VP Lead Regulatory Counsel in the assessment of regulatory pathways for new products and product modifications
• Remain current on regulatory issues/trends affecting the business, assessing and communicating their impact to colleagues, product development/support teams, and to others in the business
• Under the direction of the Lead Regulatory Counsel, assist in the creation or updating of regulatory standard operating procedures, work instructions, and policies to ensure compliance with regulatory and clinical study-related activities

KNOWLEDGE / SKILLS / ABILITIES:

• Substantial experience with the regulation of class III medical devices in the US
• Extensive knowledge of US medical device regulations, 21 CFR Part 812 governing investigational devices, related standards, FDA guidance documents and Good Clinical Practice standards
• Demonstrated success in the preparation and submission to FDA of premarket and postmarket regulatory submissions (PMAs, HDEs, IDEs, annual reports), including pre-submissions.
• Experience working and communicating with the US FDA’s Center for Devices and Radiological Health (CDRH)
• Demonstrated cross-functional collaboration and teamwork skills
• Demonstrated ability to understand advanced technical/scientific principles that relate to complex products and processes
• Demonstrated ability to provide technical review of data or reports that will be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
• Superb attention to detail and excellent communication skills
• Collaborative and independent working style
• Ability to organize, plan and adjust work assignments while meeting deadlines
• Eager to learn and learn quickly
• Excellent English (written and spoken); other European languages an advantage
• Office software proficiency

QUALIFICATIONS:

• Advanced degree in life sciences, health technology, law or engineering (MS, MPH, JD, etc.)

• Biostatistics proficiency, including use of statistical programs a plus

• Seven (7) years of experience in the Life Sciences industry

• Minimum of five (5) years of directly-related professional experience (Regulatory) in the medical device field, in increasingly responsible positions

OTHER:

• Ability to lift up to 20 pounds