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Regulatory Affairs Director

 

We are looking for a Regulatory Affairs Director who will be responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. They will also be responsible for assessment of device changes for regulatory implications and regulatory submissions (FDA & CE). Their duties will include managing other employees within the RA department.

The applicant must be willing to relocate to Salt Lake City, UT if not already local.

Annual Salary Range $80,000-100,000

Requirements:

    —B.S./B.A. in biological science or engineering field; advanced degree preferred
    —US & EU Regulatory Affairs Certification preferred
    —Experience working in a cross-functional team setting
    —Experience managing small teams of employees
    —A Minimum of 10-15 years of experience in regulatory approval process in medical devices industry, or equivalent level of regulatory experience is required
     a) Experience with Class II and Class III medical devices
     b) Previous experience with at least one regulatory submissions in each of the following categories: FDA IDE,
     FDA 510(k), FDA premarket approval (PMA), CE Mark and CE Mark Investigational Trial submissions, experience with  Class II and Class III medical devices, product development experience
     c) Experience with ISO 13485 Quality Systems, ISO 14971 Risk Management, MDD 93/42/EEC, MDR 2017-745, FDA  QSR regulations
     d) Experience with neurological devices and implantable electrodes is strongly preferred
    —Electrical Engineering knowledge preferred
    —Knowledge of neurodevices and EEG recording systems and electrodes preferred
    —Experience with submissions in Canada preferred
    —Ability to comprehend principles of engineering, physiology and medical device use
    —Strong organizational skills and attention to detail required
    —Experience with Microsoft based applications and general knowledge of PC functions necessary
    —Excellent oral and written communication skills
    —Excellent time management skills
    —High degree of initiative with the ability to work independently

Job Duties:

    1. Manage activities associated with regulatory approval of medical devices
    2. 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
    3. Leading external audits from FDA and Notified Bodies as needed
    4. Leading internal audits
    5. Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations
     a) Manage submission activities for a variety of device regulatory approvals including the CE mark, US PMAs, US pre-  market notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations  and device listings. Provide regulatory support on project teams
     b) Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the  geographic and discipline as relevant to assigned projects
     c) Interface with regulatory authorities on regulatory and technical matters, as appropriate
     d) Perform supplier audits as needed (may require infrequent travel)
     e) Manage the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs
     department
     f) Review of labeling changes, advertising and promotional activities, etc.
     g) Act as internal consultant on regulatory issues such as recalls or field actions
     h) Review of proposed device changes
    6. Official Correspondent for FDA facility registration and other matters
    7. Performs other assignments as required by the Management

To apply, send your resume and cover letter to jobs@blackrockmicro.com.

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