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Responsibilities:

• Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
• Provides strategic input and technical guidance on global regulatory requirements to product development
• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
• Critically assesses the impact of changing regulations on pre-approval and post approval strategies and approaches based on changing regulations
• Negotiates with regulatory authorities on complex issues throughout the product lifecycle
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
• Review and assesses proposals to regulatory authorities on regulatory paths and clinical plans
• Provides regulatory guidance on strategy for proposed product claims/labeling
• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process
• 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
• 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
• 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

Requirements:

• A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
• A minimum of 9 years of experience in an FDA regulated industry required; preferably with medical devices.
• A minimum of 7 years of Medical Device Regulatory Affairs experience required.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
• Experience in M&A and Integration activities 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.