Senior Regulatory Affairs Specialist

Natera

22d • $83,000 - $103,700 • Remote

About The Position

The Senior Regulatory Affairs Specialist prepares regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in domestic and international clinical markets. The role develops, executes, and manages procedures and systems to ensure that product development, including clinical studies, meets regulatory requirements and business objectives.

The specialist interprets U.S., European, and international regulatory requirements; advises product development teams; develops submission strategies; and assesses regulatory risks and options. The role prepares U.S. submissions for new product clearance or approval and continued market access, and compiles information for ex-U.S. regulatory associates seeking product registration or licensure. It also involves interactions and negotiations with U.S. regulatory agencies, responding to agency requests, and reviewing clinical, product-release, labeling, and promotional materials for regulatory compliance.

The position has occasional access to protected health information (PHI) in paper and electronic form. The employee must complete HIPAA/PHI privacy, general compliance, and security training as soon as possible and within the first 30 days of hire, and must maintain current status on Natera training requirements.

Requirements

• Bachelor's degree or equivalent.
• Minimum of 5 years of experience in the device/diagnostic, biologic, and/or pharmaceutical industry, preferably in regulatory affairs or equivalent.
• 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 communicate effectively verbally and in writing with people at all organizational levels and external parties.

Nice To Haves

• Degree in biological sciences, chemistry, or a related science.
• Project management experience.

Responsibilities

• Interpret U.S., EU, and international medical device and in vitro diagnostic device regulatory requirements.
• Provide regulatory guidance to product development teams.
• Develop strategies for submissions to the FDA and other regulatory agencies.
• Provide regulatory risk assessments and options.
• Prepare U.S. regulatory submissions for new product market clearance or approval and product continuance, including 510(k)s, PMAs and supplements, PDPs, IDEs, and Pre-Submissions and supplements.
• Prepare or compile information for ex-U.S. regulatory associates to register or license products outside the U.S.
• Interact and negotiate with U.S. regulatory agencies.
• Coordinate preparation of additional data or information requested by regulatory agencies and prepare responses to those requests.
• Participate in developing and reviewing product release documents.
• Review clinical protocols to ensure appropriate data are collected for regulatory submissions.
• Monitor clinical study status periodically and review analysis of resulting clinical study data.
• Recommend courses of action based on clinical data and regulatory requirements.
• Review labels, labeling, and promotional materials for compliance with applicable regulations and policies.
• Provide regulatory opinions on premarket regulatory, export, and labeling requirements.
• Complete required HIPAA/PHI privacy, general compliance, and security training within the specified timeframe and maintain current Natera training status.

Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401(k) benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior