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Responsibilities:

• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
• Evaluates proposed products for regulatory classification and jurisdiction
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
• Negotiates with regulatory authorities throughout the product lifecycle
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Assists other departments in the development of SOPs to ensure regulatory compliance
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
• Provides regulatory information and guidance for proposed product claims/labeling
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

Requirements:

• A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
• 5+ years of experience in an FDA regulated industry required, preferably with medical devices.
• 3+ years of Medical Device Regulatory Affairs experience required.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
• Thorough understanding of FDA and international medical device regulations.
• General understanding of product development process and design control.
• General understanding of regulations applicable to the conduct of clinical trials.
• Previous experience with Class II/III medical devices required
• Previous experience drafting regulatory submissions to FDA required
• Experience interacting with regulatory agencies required
• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
• Ability to analyze and resolve non-routine regulatory issues using independent judgment.
• Excellent analytical and writing skills.
• Excellent interpersonal, written and oral communication skills.
• Effective organizational skills.
• Advanced PC skills with proficiency in Microsoft office Suite, including Excel.