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Regulatory Affairs Manager
Regulatory Affairs ManagerKE Select • AU
Regulatory Affairs Manager

Regulatory Affairs Manager

KE Select • AU
11 days ago
Job description

About The Company

Join a Global Leader in Clinical Diagnostics

Be part of a world-class organisation at the forefront of clinical diagnostics innovation. Through sustained investment in research and development, this company delivers a diverse portfolio of specialty diagnostic solutions trusted by healthcare professionals in over 100 countries. With a global workforce of more than 3,000 employees, the Regulatory Affairs Manager role offers a highly credible opportunity with exceptional scope for impact and professional growth

Duties & Responsibilities

The main objective for the role would be to maintain and uphold the companies regulatory profile with TGA and other regulatory bodies. You role will be cover responsibilities including;

  • Ensure that all products comply with regulations and laws governing their importation, sale and distribution.
  • Help develop, drive and monitor the company regulatory plans and procedures. Provide strategic and technical advice to the CD / VP APAC.
  • To train and develop company talent in the regulatory area.
  • Manage key relationships with TGA and any relevant audits.
  • The role may evolve with supporting APAC regulatory efforts

Main  Responsibilities

  • Act as the local expert in RA and as the bridge to Corporate RA functions
  • and stakeholders
  • Collaborate with the commercial team to develop and execute ANZ annual Regulatory Master Plan.
  • Prepare product registration submissions for new products & change notifications to existing products, within agreed timeline in order to ensure regulatory compliance and approval ensuring all products and conformity assessments remain valid or updated accordingly
  • IVDR transition project
  • Understand and advise on relevant company Group Operating Procedures
  • Maintain up‐to‐date knowledge and information on the regulatory environment for medical devices in AU and NZ as relevant for the role.
  • Monitor updates to regulations, guidelines and policies in AU and NZ in relation to the company's product registrations.
  • Key contact and bridge for the organization to TGA, PTA and other key regulatory / industry bodies
  • Support and carry out Field Corrective Actions with Regulatory Authorities
  • Key contact for the local organization to the company in Regulatory & Quality for market vigilance and regulatory compliance activities
  • Provide RA reports to the CD and / or leadership group as required
  • Further Responsibilities

  • Roles reports directly to the Country Direct or
  • If agreed, a support function in APAC may be required or the role may evolve into a full APAC role.

  • Encourage and support internal teams and work collaboratively to contribute to achieving team business outcomes
  • Participate in meetings and represent quality-regulatory perspective to share information and provide input on issue resolution
  • Build and maintain collaborative relationships
  • Address / respond to queries and provide solutions where possible, or redirect query to relevant area
  • About You

    Education / Specialisation :

    Bachelor's Degree or higher

    Experience :

  • 5+ years' experience in field of development and implementation of RA processes / RA management, preferably in IVD or Medical Devices
  • 5+ years' experience in driving regulatory process to ensure appropriate and timely filing and approval with TGA
  • Laboratory experience
  • Experience in a similar role, looking for the next step up
  • Technical Competencies :

  • Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, IVDD, GMP, FDA Quality System Regulations, CFR
  • Experienced with the principles and system processes / tools within the RA field
  • Experienced in analysis of RA processes, particularly with respect to compliance, efficiency and effectiveness
  • Demonstrated ability to interpret and apply regulatory and related principles to the workplace
  • Competent with routine application of MS Office, and other common office software, incl. databases
  • Familiarity with the interface of software applications and instruments platform
  • Seasoned experience in using Microsoft Power Point, Word and Excel
  • Benefits

    Flexible work arrangements

    Base Salary + Yearly Performance Bonus + Allowances applicable to Job

    If you would like to learn more about the opportunity, please contact Kerry McMahon (Managing Director) of KE Select on; 0412 033 014

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    Manager Regulatory • AU

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