Regulatory Affairs Manager

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You Will Have Access To

• Career development with an international company where you can grow the career you dream of .
• Amazing health and wellness benefits and perks.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  
  

This role works for Abbott Core Lab. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Primary Job Function

• To manage the regulatory aspects of new ADD product launches and existing ADD product updates to comply with Government Regulatory and Statutory legislation in alignment with department goals.
• To liaise with internal and external stakeholders.
• Monitor changes in the regulatory environment to formulate the most appropriate company response to facilitate new and support on going registration activities.
• To manage expectations of the commercial operations with the expectation of the manufacturing and supply chain.
• To directly assist all ADD Departments in the correct positioning and delivery of ADD products to the marketplace.
  
  

Core Job Responsibilities

• Focus on Regulatory, Registration and Reimbursement strategies for new and currently registered products. Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory outcomes to support Marketing goals.
• Maintain necessary contacts with all Regulatory and Statutory bodies, government representatives and industry associations.
• Monitor changes in the regulatory environment to formulate the most appropriate company response to facilitate new and support on going registration activities.
• Be the key liaison point for all regulatory enquires across the organisation.
• Support Manufacturing and affiliate countries on all aspects of auditing and accreditation requests.
• Support, Assist and advise on Customer Tenders.
• Ensure all reportable MDI’s are filed in a timely manner.
• Review and approval of Promotional Materials in compliance with regulatory requirements.
• Manage and Maintain appropriate Licenses and Import/Export permits.
• On a timely basis, prepare or arrange for preparation, the Regulatory budgets, reports and forecasts.
  
  

Supervisory/Management Responsibilities

• Effective management of the Company’s regulatory affairs and change strategy
• To work in a collaborative environment with functional departments, i.e. Marketing, Logistics etc. to ensure regulatory compliance with TGA and other relevant Regulatory Agencies.
• Ensure that RA team members are skilled and kept up to date with changes to regulations and standards and to advise local and global colleagues of the impacts of such changes.
  
  

Position Accountability / Scope

Indicate the reporting relationships, products, budgets, throughput, level of contacts (internal and external), or other scoping measures this job is responsible for.

Minimum Education

• Science degree or Equivalent
• Detailed knowledge of how regulatory bodies in Australia and associated countries operate
  
  

Minimum Experience/Training Required

• Minimum 7 years regulatory experience within the diagnostics industry
• Minimum 5 years experience in a diagnostic laboratory, manufacturing or research setting.
  
  

Minimum Skills Required

• Proven ability to lead a team
• Influence Skills
  
  

Quality, Safety & Environmental Responsibilities

• Attend regular departmental meetings with manager/supervisor to build in continuous feedback mechanisms.
• Meet the requirements of ISO by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met.
• Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures and work practices with the intent of preventing or minimising accidental exposures to self, colleagues and/or the environment.