MDR LA Labeling Specialist

Round lake, IL 60073

Job Category: Information Technology Job Number: 116948

Job Title:             MDR LA Labeling Specialist

Location:             Round lake, IL - 60073

Duration:             6+ Months

About our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives

Job Description:

Essential Duties and Responsibilities:

  • Review the EU-MDR Labeling Gap Assessment for regulatory compliance and provide review comments to Gap Assessors.
  • Prepare or compile the Regulatory documents according to Regulatory requirements.
  • Review and Approve Labeling Contents, SOP’s & Other related documents.
  • Co-ordinate and Guide the Offshore team members for the Complex Queries.
  • Respond to QA / RA team’s Questions.
  • Responsible for managing the development and release of all Product Labelling deliverables.
  • Responsible for maintaining excellent collaborative relationships with R&D, Product Marketing, Regulatory/Quality and other business functions.
  • Develop project Plans to meet the Regulatory and Business Unit’s deadlines.
  • Lead or Represent Regulatory Affairs in Project teams.

Education

  • Bachelor’s Degree or Master’s Degree in Regulatory Affairs, Mechanical Engineering & Bio-Medical - B.E / B.Tech / B.S / M.E / M. Tech / M.S.

Requirements:

  • Strong knowledge of Medical Device Quality System Regulations & QMS (FDA 21CFR Part 820, ISO 13485, GDP, …)
  • Knowledge of EU Medical device regulation like
  • Medical Device Directive 93/42/EEC
  • Medical Device Regulation [EU MDR 2017/745]
  • Excellent written (Technical Writing) and Verbal communication skills
  • Good knowledge of Materials, Manufacturing process and capabilities
  • Ability to identify Compliance Risks and Escalate when necessary.
  • Change control Process (Tools: Track wise 8)
  • Project Management Skills (Tools: MS Project, Visio...)

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities.

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Contact:

Ram Manturu     @     ramm@askstaffing.com     -     678-487-8570

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