5 days old

Regulatory and Quality Assurance Administrator

Danaher
Belmont, MA 02478

General Summary & Overall Challenges

The Regulatory and Quality Assurance Administrator position is responsible for supporting the business to ensure Radiometer maintain and comply with all applicable regulatory, quality and legislative requirements for the portfolio of products purchased and sold by the Radiometer Pacific companies (RPAC).  The Regulatory and Quality Assurance Administrator position is responsible for ensuring RPAC meets the established standards of quality including reliability, usability and performance required for distribution and the market.

Duties and Responsibilities:

Regulatory and Compliance duties include:

1.    Provide administrative support to all Regulatory and Compliance functions including:

  • Product Registrations, Applications and Maintenance
  • FAN€™s spell out and Recalls
  • Adverse Events
  • Import Permits
  • Procedure, Policy, Process maintenance, updates and improvements
  • Internal Audits
  • CRM Database

    2.    Participate in and provide administrative support to the OH&S Team.

    3.    Gather required evidence for product compliance and submit to relevant authority.

    4.    Provide evidence of inclusions and notifications to the manufacturer/s.

    5.    Ensure Safety Data Sheets (SDS) are stores, available and compliant where required.

    6.    Maintain inclusions with TGA and notifications with Medsafe.

    7.    Maintain NICNAS registration and reporting for the import of introduced chemicals. 

    8.    Maintain various database and all associated data and information (e.g. GS1, Smartek, and IPRO).

    9.    Maintain Medical device incident reporting in relation to the Radiometer Pacific product portfolio.

    10.  Participate in the Quality Committee meeting.

    11.  Document internal audits and other quality assurance activities.

    12.  Investigate customer complaints and other non-conformance issues.

    13.  Collect and compile statistical quality and regulatory data.

    14.  Analyse data to identify areas for improvement in the business, specifically the CRM.

    15.  Monitor and report on corrective and preventive actions.

    16.  Prepare reports to communicate outcomes of quality activities

    17.  Responsible for document management systems

    18.  Any other duty as may be required.

    19.  Maintain corporate confidentially at all times

    Qualifications:

    Academic

    Essential

    Bachelor degree in appropriate field or a proven record of at least 5 years€™ work experience with similar skills.

    Desirable

    Postgraduate, industry, society qualifications.

    Knowledge Skills & Experience

    Essential

    Proven track record and similar experience of supporting detailed administration processes.  

    Document and contract management skills.

    Intermediate to advanced IT literacy across all Microsoft Applications.

    Desirable

    Experience in regulatory and quality requirements in any industry.

    Understanding of commercial requirements for Regulatory and Quality.

    Working with cross-functional teams.

    Ability to effectively present and interact with all levels of an organisation.

    Personal Qualities:

    Essential

    Pragmatic with high integrity and a strong drive for doing things professionally.

    Highly organised with high attention to detail.

    Ability to work under pressure and to strict deadlines.

    Analytical and problem solving skills.

    Outstanding documentation, written and oral communication skills.

    Proactive approach to tasks and learning.

    Ability to work independently and self-manage.

    Advanced interpersonal & teamwork skills

    Desirable

    A strong communicator.

    Highly conscientious and team focused.

    Strong goal and achievement focus.

    Ability to interpret and assess a requirement and identify any potential impact to the business.

    What we offer:

Categories

Posted: 2020-05-21 Expires: 2020-06-20

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Regulatory and Quality Assurance Administrator

Danaher
Belmont, MA 02478

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