29 days old

Regulatory Affairs Specialist, Senior (CDx)

Roche
Tucson, AZ

Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications.

ESSENTIAL FUNCTIONS:

  • Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
  • Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
  • Responsible for maintenance of product technical files and for ongoing activities related to compliance with global directives and regulations.
  • Assist in submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
  • Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
  • Interface with regulatory authorities on regulatory and technical matters, as directed.
  • May provide regulatory support on project teams.
  • Assist in the creation of Operating Procedures and policy guidelines.
  • Assist in review of labeling changes, advertising and promotional activities, etc.
  • May assist as the internal regulatory consultant for on-market product issues.
  • Assist in review of proposed device changes.
  • May perform other duties as required or assigned.

MINIMUM QUALIFICATIONS:

Formal Training/Education:

  • B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred.  Regulatory Affairs Certification preferred.

Experience:

  • Minimum 3 years experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. Regulatory affairs experience is preferred. IVD device experience is preferred.
  • Experience with regulatory submissions including IDE, 510(k), and PMA submissions is preferred.
  • Experience working in a cross-functional team setting is preferred.

Knowledge, Skills, and Abilities:

  • Strong organizational skills and attention to detail required.
  • Experience with Microsoft based applications and general knowledge of PC functions necessary.
  • Ability to work in a fast-paced/entrepreneurial team environment.
  • Results and goal oriented.
  • High degree of initiative with the ability to work independently with minimal supervision.
  • Excellent oral and written communication skills.
  • Ability to prepare and present concise information to groups.
  • Ability to comprehend principles of engineering, physiology and medical device use.
  • Ability to plan and organize work while remaining flexible.
  • Excellent time management skills.

Posted: 2018-11-20 Expires: 2018-12-20

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Regulatory Affairs Specialist, Senior (CDx)

Roche
Tucson, AZ

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