Director of Regulatory and Compliance

Director of Regulatory and Compliance

Southern California

Responsibilities:

  • Create, implement, and oversee regulatory and operational strategy and tactics for products that require domestic and foreign government approval.
  • Be an internal and external-facing credible regulatory expert, to be relied upon to articulate clear and compelling regulatory strategy, highlighting risks and opportunities.
  • Expertise in all aspects of assigned functions, including development and management of compliance plans, reporting systems and controls.
  • Provide timely and practical compliance advice and support to assigned business teams by advising on program/initiative strategy, design, execution, internal and external content.
  • Develop and implement innovative global regulatory strategies for new and/or existing products.
  • Write and oversee pre-submissions, 510(k)s, PMAs, IDEs, Technical File, Post Market Reports, etc.
  • Ensure compliance with global regulations and regulatory agencies, including the FDA.
  • Advise management on the company’s compliance with laws and regulations through detailed reports.
  • Create and manage effective action plans in response to audit discoveries and compliance violations.
  • Regularly audit company procedures, practices, and documents to identify possible weaknesses or risks.
  • Responsible for compliance to product regulatory demands and interpretations worldwide.
  • Ensure risk management processes are followed for all compliance activities to meet global regulatory compliance.
  • Keep ahead of domestic and international regulatory requirements, changes and monitors outcomes of initial product concepts, and provides input to the executive team.
  • The owner of international contact to ensure fluid product change and regulatory notification.
  • Provide compliance support in the specific areas of Internal Audits, External Audits, and Audit Readiness, and ensure ongoing effectiveness of these systems.
  • Develops and coordinates plans to identify, address, and mitigate potential risks to compliance to support Company’s activities.
  • Oversee other teams/departments to ensure the correct direction and accuracy of product regulation.
  • Leads department through regulatory due diligence.
  • Review and approve claims, labeling, and advertising, etc.
  • Determine when exemptions can be used.
  • Hold process review meetings with internal departments.
  • Resolve employee concerns about legal compliance.
  • Initiate process improvements and systems enhancements as identified.
  • Participate in departmental continuous improvement activities and maintain awareness of current, pertinent regulations, guidelines, policies, procedures, and practices.
  • Provide effective communication for continuing regulatory education throughout related departments.
  • Dissemination of regulatory information to product development, marketing, and clinical affairs organizations.
  • Review and approve protocols and reports (i.e. design verification & validation, biocompatibility, etc.)

Qualifications:

  • Bachelor’s degree in a scientific discipline or related field (Master's or Ph.D. a plus)
  • Class I, II & III US regulations and equivalent regulations understanding across Canada, Brazil, China, Europe, and ROW
  • Documented competence in leading domestic and international audit programs
  • Experience with regulated devices with software or software as a medical device
  • Fundamental competence in FCC, UL, CSA, and CE regulations
  • Familiarity with ISO standards, 21CFR 820, and CE marking processes
  • Risk management experience (ISO 14971:2019)
  • Roughly 4-8 years of experience in all aspects of Global Regulatory Affairs in the Medical Device Industry
  • Comprehensive understanding of US and international medical device regulations/standards and quality principles
  • Ability to effectively interface with all levels of management, notified body, and regulatory agency representatives
  • Proactive & timely, strategic global regulatory guidance
  • Technical writing skills
  • Attention to detail 
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