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Regulatory Affairs Senior Manager-IVD

  • Job type: Permanent
  • Location: San Diego
  • Salary: $140000 - $150000 per annum, Benefits: Bonus + Stock
  • Job reference: MSLN7112017
  • Sector: EPM Scientific, Regulatory
  • Date posted: 11/07/2017
 
Location: Temecula, CA
Salary: $140K-150K


This industry leading client offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.


Responsibilities:

  • Research, prepare, and update clinical protocols, instructions for use, informed consents, reports of prior investigations, bibliography, case report forms, clinical trial reports, and other study-related documents in consultation with the cross-functional project team, investigators, data management and FDA.
  • Responsible for coordination/execution of all operational aspects of clinical studies, including study start-up, follow up, study closure activities.  Provide Clinical / Regulatory representation during audits.
  • Performs monitoring and auditing at participating sites to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.
  • Conduct ongoing review of adverse event information. Compile and update adverse event logs. May interface with Regulatory agencies, as appropriate.
  • Conduct/supervise training of investigators, site staff, and internal clinical staff. Conduct/supervise site initiation activities. Set-up and maintain (or supervise) accurate study status and accountability logs.
  • Review data listings and tables. Educate internal/external data management on the clinical context of these documents and provide oversight of data reconciliation.
  • Evaluate clinical data/information, write, and revise annual, interim, and final reports and clinical sections of Regulatory submissions.
  • May organize investigator conferences to review findings and advise on study direction, as needed.
  • May provide input and support for post-clinical activities and market launch of products.
  • Act as both the Regulatory and Clinical resource for New Product Development teams, assuring that project scheduling can be accurately compiled factoring in necessary clinical studies and Regulatory applications/approvals.
  • Write domestic and international regulatory submissions, to include Design Dossiers for CE marking and technical files.
  • Perform surveillance and advocacy for relative regulations on a global basis  
  • Maintain Regulatory Registrations and licenses
 
Who you are:
  • Strong knowledge in FDA 21 CFR 820, CMDR SOR 98-292, IVDD EN 98/79/EC, ISO 13495:2003, International Medical Device Regulations.
  • Knowledgeable in Electronic and Electrical Equipment regulations 
  • Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.   
  • Strong Computer skills (MS Office products, word processing, spreadsheets, etc.).   
  • Ability to multi-task. Strong prioritization and organizational skills.       
  • Strong problem solving skills.  Knowledge of principles of clinical research study design. 
  • Strong knowledge of Good Clinical Practice (GCP) and Regulatory compliance guidelines and regulations for clinical trials. 
  • General experience in medical device manufacturing,
  • Regulatory requirements / submissions, and worldwide experience in medical devices from the Regulatory and clinical perspectives. 
  • Strong motivator/communicator in a compact clinical team working with aggressive timelines.  
  • Good communication/negotiation skills with clinical investigators and academic thought leaders highly professional demeanor.
 

 

 

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