Regulatory Affairs Specialist - IVD, gap assessments in Oro Valley, AZ at Apex Life Sciences

Date Posted: 9/27/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a Regulatory Affairs Specialist to manage activities associated with regulatory approval of in vitro diagnostic medical devices. This individual will be responsible for activities which lead to and maintain domestic and international regulatory approval to market devices.

Responsibilities:

  • 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 Regulatory directives and regulations.
  • Manage 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, annual reports, export certificates, and establishment registrations and device listings.
  • May review, interpret, and report to the head of Regulatory Affairs on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer. May work with the head of Regulatory Affairs to develop strategic and tactical responses to influence a reasonable regulatory environment.
  • Responsible for adherence to departmental budgets.
  • 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 appropriate.
  • Manage the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department
  • Provide regulatory support on project teams.
  • May serve as Functional Lead on Lifecycle or project teams.
  • May provide consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues.
  • May perform other duties as required or assigned.

Qualifications:

  • B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred. Regulatory Affairs Certification preferred.
  • 5+ 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 desired.
  • Experience with regulatory submissions including IDE, 510(k), and PMA submissions is preferred.
  • 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 environment.
  • Ability to work in a cross-functional, highly interdependent team structure
  • Results and goal oriented.
  • High degree of initiative with the ability to work independently.
  • Proven experience in managing budgets is preferred.
  • Excellent oral and written communication skills.
  • Ability to prepare and present 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.

**For immediate consideration, please email your updated resume to ksavas@apexlifesciences.com with 'Regulatory Affairs Specialist AZ' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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