Senior Staff Specialist, Regulatory Affairs

Location: Crystal Lake, IL Salary: $60.00 USD Hourly - $62.00 USD Hourly Description:
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, Google Cloud Platform 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

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