Regulatory Affairs Specialist in Victoria VIC

Full-time @Steris in Healthcare , in Medical Equipment , in QA , in Quality , in Quality Assurance , in Research , in Technology
  • Victoria, VIC, AU, Vic 3189 View on Map
  • Apply Before : November 15, 2022

Job Description

Join Steris as Regulatory Affairs Specialist in Victoria . At the Steris you will perform tasks as listed below, Apply Steris Regulatory Affairs careers in Victoria VIC.

 

Position : Regulatory Affairs Specialist

Job Category: Regulatory Affairs

Work location : Victoria,

Job Segment : Medical Equipment, QA, Quality Assurance, Quality, Healthcare, Technology, Research

 

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
We are seeking a Regulatory Affairs Specialist who will be responsible for ensuring all regulatory activities for a fast-growing medical equipment company, and its customers, adhere to the requirements of regulatory bodies and company standards. The successful candidate will have a proven experience working within a fast paced and deadline driven environment and whose highly developed attention to detail and research skills to maintain regulatory compliance of all new and existing products will see them excel in this role.
Duties

Work in close collaboration with the Manager Quality Assurance and Regulatory Affairs and the Lead Regulatory Affairs
Manage the range of products to ensure compliance with all internal and external regulatory requirements for Australia
Manage compliance requirements, such as licence renewals, registrations, variations, notifications, reports, and submission to the regulatory authorities
Prepare, collate, and compile documentation
Responding and following up on any regulatory affairs issues and customer enquiries

Required Experience
To be successful in this role, you will be able to demonstrate that you:

are familiar with the standards and regulations of Therapeutic Goods Administration (TGA)
basic knowledge of ISO 13485 standards
are a self-starter and highly organised
can perform assigned tasks in a highly complex environment
have previous demonstrated international experience in a similar capacity within an RA function in the Healthcare sector
have a strong understanding of local regulations and the ability to exercise judgment regarding which approaches are acceptable for meeting regulatory requirements and to timely recognize and communicate significant regulatory or compliance issues for resolution to Regulatory management.
have strong interpersonal skills with the ability to influence and negotiate with key stakeholders (both internal and external) and facilitate corrective action
Degree qualified in a relevant discipline

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.

Job Tags : Steris careers in Victoria, Regulatory Affairs jobs in Victoria VIC, Medical Equipment jobs hiring, QA jobs in Victoria, Quality Assurance careers, Victoria jobs in Medical Equipment sector, Jobs nearby in Victoria , Steris hiring nearby me in Victoria VIC, Quality jobs,

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Required skills