Staff Regulatory Affairs Specialist

****12 months fixed term contract (Hybrid role)****

Key Areas of Responsibility

• Provides regulatory affairs support to the Patient Specific Solutions business to achieve timely approvals of custom devices via custom and compassionate use pathways.
• Assesses regulatory intelligence to assist in the development of local regional and global regulatory strategies
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Identifies requirements and potential obstacles for market access distribution.
• 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
• 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
• 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
• 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

Education/Work Experience

• BS in Engineering Science or related or MSc in Regulatory Science or Clinical Science
• Typically a minimum of 4 years experience
• RAC(s) preferred

Knowledge/Competencies

• Strong project management writing coordination and execution of regulatory items
• Emphasis on technical clinical and scientific regulatory activities
• 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
• Reviews progress and evaluates results
• Recommends changes in procedures
• Operates with appreciable latitude for unreviewed action or decision
• Reviews progress with management
• May direct work of Specialist or Sr. Specialist
• 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