Job Description

Work Flexibility: HybridWho we want
Hard-working winners. Confident, competitive and results-oriented professionals who create a track record of success.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.Position Summary:This position will be responsible for possessing and applying broad and advanced knowledge, setting direction and regulatory strategy, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Responsible for Leading team of Regulatory professionals to ensure regulatory compliance by driving implementation of selected regulatory requirements at the local, state, or federal/regulatory agency levels. Responsible for developing talent within team to increase performance.
Supporting new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supporting the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensuring regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Serves as a divisional resourceWhat you will doGeneral Responsibilities:\xc2\xb7 Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy. Participates in advocacy activities of a more advanced strategic nature\xc2\xb7 Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies\xc2\xb7 Provides guidance to integrate regulatory considerations into global product entry and exit strategy\xc2\xb7 Works with little to no supervision or instruction. Expected to take on leadership role on significant projects. Acts as divisional technical mentor / lead of others in department. Demonstrates advanced technical leadership skills and influence outside of department\xc2\xb7 Makes informed decisions based on business frameworks and tools and give consideration to risks tradeoffs, timing, and available resources\xc2\xb7 Identifies regulatory pathways for initial product designs and provides input to internal stakeholders\xc2\xb7 Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes\xc2\xb7 Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles\xc2\xb7 Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations\xc2\xb7 Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)\xc2\xb7 Negotiates with regulatory authorities on complex issues throughout the product lifecycle\xc2\xb7 Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution\xc2\xb7 Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures\xc2\xb7 Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance\xc2\xb7 Provides strategic input and technical guidance on global regulatory requirements to product development terms\xc2\xb7 Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions\xc2\xb7 Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions\xc2\xb7 Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans\xc2\xb7 Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases\xc2\xb7 Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships\xc2\xb7 Provides regulatory guidance on strategy for proposed product claims/labeling\xc2\xb7 Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims\xc2\xb7 Manages electronic (eCTD) and paper registration development\xc2\xb7 Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions\xc2\xb7 Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process\xc2\xb7 Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committeesTasks may include:\xc2\xb7 Consistently managing simple and complex projects\xc2\xb7 Leading SOP development and review\xc2\xb7 Leading the development and update of regulatory strategy based upon regulatory changes\xc2\xb7 Providing regulatory strategy and input to new product development and product lifecycle planning\xc2\xb7 Mentoring junior staff members\xc2\xb7 Evaluating regulatory impact of proposed changes to launched products\xc2\xb7 Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications\xc2\xb7 Determining and communicating submission and approval requirements\xc2\xb7 Participating in risk-benefit analysis for regulatory compliance\xc2\xb7 Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actionsAdditional tasks may include:\xc2\xb7 Maintaining annual licenses, registrations, and listings\xc2\xb7 Reviewing regulatory aspects of contracts\xc2\xb7 Ensuring compliance with product post-approval or clearance requirements\xc2\xb7 Approving labeling, advertising and promotional items for compliance before release\xc2\xb7 Reviewing publicly disseminated information to minimize regulatory exposure\xc2\xb7 Reviewing product claims and preserving confidentiality of applicable product information\xc2\xb7 Providing regulatory input for and appropriate follow-up to inspections and audits\xc2\xb7 Assisting in the development and implementation of SOPs and systems to track and manage product-associated events\xc2\xb7 Reviewing change management to determine the level of change and potential submission requirements\xc2\xb7 Identifying product-associated problems and developing proposals for solutions\xc2\xb7 Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications\xc2\xb7 Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies\xc2\xb7 Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements\xc2\xb7 Monitoring impact of changing regulations on submission strategies\xc2\xb7 Identifying issues early in the submission preparation process that could impact product launch\xc2\xb7 Compiling, preparing, reviewing and submitting regulatory dossiers to authorities\xc2\xb7 Participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance\xc2\xb7What you need:\xc2\xb7

• B.A. or B.S.in Science, Legal, Regulatory or Engineering, or equivalent
• RAC certification preferred.
• Advanced Certifications or Development Expected
• Industry Working Group/Committee Participation Desired
• 9+ years experience

Qualifications & experience:

• 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, post-market 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
• Minimum of 9 years of regulatory experience in the medical device or pharmaceutical industry

Physical & mental requirements:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements listed here are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.Travel Percentage: 10%

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