Job Description

We are currently seeking a  Regulatory Affairs Specialist to join our Compliance team; this position is Remote/Hybrid in the USA. Preference to Eastern and Central states to align with global partners.

Responsibilities

Possesses and applies knowledge, skills/abilities, and understanding of the regulatory and legal frameworks, regulatory requirements, and processes and procedures focused in the areas of our medical and healthcare portfolio. This includes but is not limited to cloud and other connected devices and platforms. This position will work in close collaboration with partners to provide knowledge and guidance to new product development teams.

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• 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.
• 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..
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with 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.
• Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
• 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.
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

Preferred Qualifications

• A minimum of a Bachelor's Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
• A minimum of 5 years of experience in an FDA or highly regulated industry required.
• A minimum of 2-3 years in a Regulatory Affairs role required.
• Experience with software as a medical device, Agile development, and/or artificial intelligence preferred.

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