מנהל.ת רגולציה

תיאור תפקיד

לחברת מדיקל מצליחה ביקנעם דרוש.ה מנהל.ת רגולציה מנוסה בעל.ת 7 שנות ניסיון בעולמות המדיקל.

Key responsibilities:                                                                                                           

  • Ensuring awareness and compliance with worldwide medical device related regulatory requirements, throughout the organization
  • Providing accurate regulatory input into all QA policies and systems, including assessments of QMS related activities (e.g., CAPA, ECOs, MRBs, changes to the QMS etc.) for ensuring compliance with all relevant standards and regulations
  • Maintaining up-to-date knowledge of international regulatory requirements
  • Involvement and guiding the product development from concept onward, including determination of necessary testing and validations according to relevant standards
  • Providing regulatory intelligence assessments, defining and directing innovative and effective international regulatory strategies and timelines for new and potential products
  • Leading and overseeing world-wide regulatory submissions from preparations via reviewing and toward liaisons with health authorities and regulatory bodies till final approval/clearance
  • Preparation and maintenance of technical files
  • Leading post marketing related activities including clinical evaluation reports, PMS, customer complaints and AE, MDR, marketing materials review, annual licenses and the like
  • Evaluating, monitoring and reporting regulatory compliance of products and processes and be focal point for internal and external changes, deviations or investigations related to products or processes
  • Identifying of regulatory risks, deep involvement in overall products’ risk analysis and mitigations

 

Qualifications:

  • Significant knowledge of medical device regulations and international standards
  • At least 7 years of experience in a medical device regulatory environment
  • At least 3 years of experience in managing direct report, preferably regulatory team
  • At least MSc in biological sciences, engineering, or related field
  • Demonstrated track record of accomplishments with regulatory submissions
  • Ability to analyze and interpret scientific and technological data and regulations
  • Multidisciplinary approach, ability to prioritize and independently work and manage multiple projects per predetermined restricted timelines
  • Hands on, motivated, decisive, roll-up-your-sleeves approach
  • Team leader with coaching, mentoring and knowledge sharing approach
  • Outstanding organizational and planning skills with high attention to details and accuracy
  • Interpersonal skills to communicate effectively across multiple departmental lines
  • Problem-solving innovative approach, and negotiation/decision making skills
  • Highly proficient verbal and written communication skills in English
  • Intellectually curiosity with critical, strategic and analytical thinking skills

 

 

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