Regulatory Affairs Leader

Core responsibilities:

• Develop and implement regulatory strategies that integrate scientific, regulatory and business considerations to support product development, manufacturing, distribution and lifecycle management in compliance with applicable global requirements.
• Prepare, lead all aspects of and maintain regulatory submissions and technical documentation, including: EU MDR (European Regulation 2017/745 on Medical Devices) technical documentation, submissions and processes to support sustained CE marking, change notifications, certificate renewals, technical reports and agency certifications.
• Provide regulatory guidance and recommendations based on policies, standards and authority expectations to balance business objectives with regulatory risk, anticipate emerging issues and obstacles, and communicate business-related risks or opportunities to management.
• Review and approve product release status, marketing materials, product development documentation, FMEAs, test plans and reports, product specifications, labeling and other regulatory results as required.
• Partner with cross-functional teams, including Quality, Clinical, Post Market Surveillance, R&D, Manufacturing and Marketing, to incorporate global marketing strategies into regulatory plans and ensure compliance with MDR, ISO 13485 and other applicable regulatory and quality system requirements.
• Identify, develop and enhance regulatory policies, processes, SOPs and quality system practices; coordinate compliance activities, including vigilance reporting; and lead regulatory projects and employee training as needed.
• Manage budgets for product registrations and renewals, perform other duties as assigned, and ensure personal, Company and, where applicable, team compliance with all Federal, State, local, Company, Health, Safety and Environmental regulations, policies and procedures.
• Lead interaction with European Notified Bodies and internal and external inspections as for ISO 13485 and MDR requirements.

Qualifications:

• Bachelor’s degree or equivalent in Engineering or Science or related discipline.
• 7-10 years of work experience in Regulatory Affairs
• 5+ years prior MDR/MDD/CE mark submissions
• Background in preparing major regulatory submissions and supportive amendments or supplements, and collaborating with regulatory authorities
• Experience in interpretation of regulations, guidelines, policy statements, etc.

Required Skills:

• Strong social skills with the ability to partner effectively with medical, scientific, manufacturing and other cross-functional stakeholders.

• Ability to read, analyze and interpret engineering specifications, scientific information, professional journals, technical procedures and government regulations.

• Experience developing reports, specifications and complex regulatory submissions, including IDE, PMA, CE Design Dossiers and Technical Files.

• Ability to present information clearly and respond effectively to questions from internal stakeholders and external regulatory agencies.

• Strong problem-solving skills, including the ability to define issues, collect and assess data, establish facts and draw valid conclusions.

• Ability to review technical and clinical literature and documents and extract key concepts relevant to regulatory strategy and execution.

• Experience interacting with auditors and Competent Authority representatives and managing internal and external audits in accordance with established processes, procedures and international standards.

• Ability to lead, influence and align project teams to achieve shared goals.

• Experience engaging senior management on significant matters requiring coordination across organizational units.

• Ability to balance strategic and tactical priorities, moving effectively between high-level perspective and detailed execution.

• Knowledge of Quality Management System requirements for medical devices, particularly ISO 13485.

Preferred Skills:

• Graduate Degree in Engineering or Science or related discipline and/or Regulatory Affairs Certification (RAC) preferred.

• Experience with MDR Class III Risk Medical Device necessary

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility