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 Director
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
