Senior Staff Regulatory Affairs Specialist

 

Description:

Key Areas of Responsibility:

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies

• Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature

• 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.)

• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

• Evaluates proposed products for regulatory classification and jurisdiction

• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

• 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 and sustaining teams

• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

• Assesses the acceptability of quality, preclinical, and clinical documents for submission filing to comply with applicable regulations

• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategies (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

• 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

• 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

• Works with cross-functional teams for interactions with regulatory authorities, including panel meetings and advisory committees

• Remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k)

• Remediation of EU MDR Technical Documentation File in accordance with relevant regulatory requirements for Class IIa medical device

 

Education / Work Experience:

• BS in Engineering, Science, or related degree; or MS in Regulatory Science

• Typically a minimum of 6 years’ experience

• MS or RAC(s) preferred