Job Details

• The position supports the Quality and Regulatory efforts including national and international applications and handling for products, developing technical files to ensure regulatory compliance and assist in identifying medical device/ drugs regulations for various geographies.
• In addition, this position will work with the quality team to improve and maintain the Quality Management System and strategies to ensure regulatory and product standard compliance.
  

Summary Of Responsibilities

• Support product registration and regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets.
• Assist the VP of QA/RA in developing and implementing quality strategies. Improve quality system / procedures to maintain compliance with ISO 13485:2003. Coordinate and support internal and external audit.
• Maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and agency guidelines.
• Provide support for quality systems improvements, and business process improvement initiatives.

Key Responsibilities

• Support productas registration and regulatory submissions for new and existing products including FDA 510(k), Drugs Dossiers, Technical Files, Canadian Device License Applications, and internal \"Letters to File\".
  
• Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
  
• Review and sign off on product and manufacturing changes for compliance with applicable regulations.
  
• Create and review documents used in good manufacturing practices; monitor audits of production and quality control areas.
  
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
  
• Create Installation Qualification, Operational Qualification and Performance Qualification protocol, execute and complete reports.
  
• Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
  
• Manage non conformance, corrective action preventive actions and deviation.
  
• Create, review and approve test protocols (as needed) to support regulatory submissions and testing.
  
• Create and update Risk Management and provide input in design verification, design validation, shelf life studies.
  
• Investigate complaints, create reports and document them. Take action on reportable complaints.
  
• Conduct material qualification testing for all the new raw materials to be used for production.
  
• Manage and renew all the regulatory registrations.
  
• Support new products development projects.
  
• Collaborative, flexible and able to complete other assignments as needed.
  

KNOWLEDGE & EDUCATION

• Bachelor Degree in Science or equivalent; preferred Masters Degree.
  
• 2 to 3 years experience is preferred
  
• Knowledge of FDA medical device and drug regulations, guidance, and import/exports requirements.
  
• Knowledge of European Medical Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.)
  
• Knowledge with medical device labeling and promotional requirements.
  
• Strong understanding of the quality system and ISO13485 regulations
  
• Knowledge or experience in Risk management
  
• Knowledge of QS regulations preferred.
  
• Statistical analysis and problem-solving ability strongly preferred

• Proficient in timely review of technical and clinical data.
  
• Proficient in FDA and international regulations (EU and Canada)
  
• Good presentation skills.
  
• Excellent computer skills - proficiency with MS Office products
  
• Strong written and oral communications skills; strong technical writing skills.
  
• Detail oriented and self-motivated.
  
• Ability to write clear, concise, and well thought out technical documents.
  
• Able to manage moderately complex problems/projects by exercising independent decision making and analytical thinking skills
  
• Ability to work under minimal supervision and independently.
  
• Must be able to work in a timeline-driven environment.