Senior Staff Specialist, Regulatory Affairs

Job Title: Senior Quality/Regulatory - Senior Staff Specialist, Regulatory Affairs


Location: Cary, IL


Duration: 12+ Months Contract

Job Description:


This is a highly specialized individual contributor role that requires deep expertise from a professional / technical thought leader in their respective field or discipline. This position typically requires extensive experience in a specialized field and an advanced college degree or equivalent. The role requires expertise within a discipline in a specialized field. The job provides technical guidance and direction for his/ her area of specialization. The job requires good analytical skills as well as evaluative judgement based on the analysis of factual and qualitative information in complicated or novel situations. The complexity implied at this level of problem solving relates to the ability to filter, prioritize, analyze and validate potentially complex and dynamic material. This job typically requires a degree or equivalent and a minimum of 6 or more years' experience.


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 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
• 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


Knowledge / Competencies:
• Thorough knowledge and understanding of US and International Medical Device Regulations with direct experience in US 510(k) and EU Class IIa devices.
• Working knowledge of EU MDR Class IIa devices with expertise in maintaining a Technical Documentation File.
• Technical and management skills and engaged in regulatory strategy and operations
• Demonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance; and distribution
• Under general supervision, plans, conducts and supervises assignments
• Proactively reviews progress and evaluates results
• Proactively recommends changes in procedures
• Operates with appreciable latitude for unreviewed action or decision
• Reviews progress with management
• Seeks out diverse ideas, opinion, and insights and applies them in the workplace
• Connects and relates well with people who think and act differently than oneself
• Embraces scrutiny and accepts feedback as opportunity to learn and improve
• Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
• Navigates the dynamics, alliances, and competing requirements of the organization or business
• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities