Quality Systems and Regulatory Specialist

East Bay, (none selected) | Direct Hire

Post Date: 08/03/2016 Job ID: 1076 Industry: Consumer Electronics / Appliance

As a uniquely qualified candidate, you will:

  • Understand and influence the company on requirements of Regulatory Agencies such as FDA, BSI and standards-setting organizations such as ISO, AAMI and ANSI.
  • Ensure labeling is consistent with product regulatory affairs approvals.
  • Manage legal marketing status of products globally.
  • Provide interpretation and guidance on regulatory affairs requirements and laws for new and existing products.
  • Write, review, document, and implement requirements into NDC procedures.

Essential Duties and Responsibilities include the following. (Other duties may be assigned):

  • Prepare and submit original registrations, amendments, supplements, variations, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements including but not limited to Canada, Singapore, Taiwan, Indonesia, Russia, India, and Slovakia.
  • Assist in preparation of regulatory strategies and identification of regulatory requirements for submissions to insure the efficient approval and registration of products.
  • Provide regulatory affairs guidance to project teams.
  • Prepare and submit 510k’s and technical files to regulatory bodies as needed for CE mark approval, CE supplement approval and 510k approval.
  • In a QA role, and as part of QA department, support ISO13485/CMDCAS, FDA QSR and medical device directives compliance activities throughout organization including, but not limited to, CAPA system, supplier evaluation system, and internal audit system.
  • Maintain abreast of regulatory changes through industry publications, seminars, and government meetings, and provide interpretation of regulatory affairs standards and guidance.
  • Be responsible for following all company guidelines related to Health, Safety and Environmental practices and assure that all resources needed to do so are available and in good condition.
  • Data Retention/Records Management.

Education and/or Experience:

  • BS in a related field of study; and 7 or more years of related experience and/or training in combined background in both Regulatory Affairs and Quality System areas; or MS with 5 or more years; or equivalent knowledge and skills, necessary to satisfactorily perform the position responsibilities.
  • Experience in dealing with the Food & Drug Administration and other regulatory agencies.

Other Skills and Abilities:  Good written and oral communication skills.  Ability to select, manage and direct a team during an audit.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.  Ability to use PC's and associated software.  Ability to effectively interface with governmental and independent auditors.

Work Environment: While performing the duties of this job, the employee is regularly required to sit and stand for long periods of time.  Specific vision abilities required by this job include close vision.  While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles and risk of electrical shock.

 


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