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June

Post Market Quality (Regulatory Reporting) Specialist

Cook Group - Eight Mile Plains, QLD

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

Overview:

  • Privately owned Global Medical Device Manufacturer
  • Attractive employee benefits
  • Strong inclusive culture that values our people

We are looking for a hard-working, reliable and motivated individual to join our friendly, well respected and long-established company.

Fantastic opportunity to contribute your skills and experience to this permanent Regulatory Reporting role.

You will be joining a high-performing team where you can establish positive working relationships with internal and external stakeholders.

At Cook Medical, we are passionate about the work that we do in making a difference to patient lives around the globe. We treat everyone with respect and encourage our employees to be transparent, through open and honest communication and being appreciative of individual contribution.

Responsibilities:
Key Responsibilities:

  • Perform all tasks in accordance with the Quality Management System to a competent standard
  • Ensure Compliance to the complaint handling and regulatory reporting procedures, including vigilance and field safety corrective action reporting
  • Assess complaints for reportability to regulatory authorities
  • Liaise with the Regulatory Reporting Lead, Heads of QA, RA and Medical Director to guide decision-making, as required, regarding potentially reportable events
  • Submit initial, follow-up and final device incident reports to regulatory authorities within the required timeframes
  • Submit field safety corrective action reports to regulatory authorities within the required timeframes
  • Provide additional information regarding reportable events/field actions/other enquiries to regulatory authorities as required
  • Liaise with other Cook companies regarding reportable events/field actions as required
  • Conduct peer reviews of new complaint entries for completeness and accuracy
  • Conduct Manufacturer Final Reviews of complaint records by reviewing complaint records for completeness, within timelines
  • Report complaint trend activities as required
  • Contribute to appointed metrics and work within defined timelines
  • Maintain vigilance procedures in compliance with applicable regulatory requirements
Qualifications:
Key Requirements:

  • Bachelor’s Degree in related field or experience of such kind and amount as to provide a comparable background is essential
  • Experience working within a Regulatory/Quality and/or Vigilance role desirable
  • Experience working in a highly regulated industry such as medical devices desirable
  • Intermediate Microsoft Office proficiency (Excel, Word, PowerPoint) essential
  • Knowledge of relevant regulatory requirements for Australia, USA and EU is desirable
  • Demonstrated ability to meet deadlines, balance multiple priorities and ensure quality standards are met
  • Analytical approach to problem solving with innovative thinking
  • Highly organised with a focus on attention to detail
  • Approach daily tasks with flexibility, initiative and enthusiasm
  • Highly developed communication and interpersonal skills
  • Ability to work effectively in a team environment

Cook Can Offer:

  • Stability of a long-established company
  • Values recognition and service awards
  • Performance based quarterly bonus
  • Top Hospital Private Health Cover for immediate family
  • Subsidised cafeteria
  • Flexible start/finish times
  • Ongoing training and development
  • Strong inclusive culture that values our people

Candidates applying to this role must be a permanent resident or citizen of Australia.

This role is to commence as soon as possible and shortlisting will commence immediately.

About Cook Medical:

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials, and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently.

Headquartered in the United States, we also have manufacturing locations in Denmark, Ireland and Australia. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities.

As a global, modern company we ensure that our company values reflect our everyday business practices, staying true to what Bill and Gayle Cook started in 1963.

At Cook Medical, we embrace diversity and inclusion. We understand that everyone can offer a unique perspective and can contribute their own ideas to improve how we work. We strive to create an environment where our employees can feel empowered to make decisions and can bring their full, authentic selves to the workplace.

We are seeking conscientious employees who align with our values, and we encourage people of all genders, races, ages and abilities to apply for roles within our organisation.

For more information please visit www.cookmedical.com.au/careers

The future of medical care has never been more exciting.

Eight Mile Plains, QLD

Health, Medical & Pharmaceutical




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