Senior Staff Specialist, Regulatory Affairs

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