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Job Title:  Lead Regulatory Affairs

Req ID:  32444
Job Category:  Regulatory Affairs

Victoria, VIC, AU, Vic 3189

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

Reporting to the Manager Quality Assurance and Regulatory Affairs we are seeing a leader for our Australian Regulatory Affairs team. The key remit for this role is to support the development and administration of the global regulatory policy positions across the product lines of our various businesses by preparing international submissions for product approvals to meet Australian and New Zealand regulatory requirements.

The incumbent will also provide support for plans to achieve identified corporate regulatory policy objectives by keeping abreast of and providing regular reporting to key business leaders on regulatory developments that impact our customers, or our business directly. This is also a supervisory position and will be responsible for one direct report.

Duties

Your key responsibilities will include:

  • obtainment of product and country market registration requirements and compliance to regulation to support the needs of our customers
  • provide supervision and guidance regarding preparation of Regulatory Submissions for the company's portfolio of products
  • identify regulatory requirements for new products or product enhancements in the product development cycle
  • act as the liaison for local and international regulatory bodies for any major queries regarding submissions
  • review product revision requests to assure compliance with regulatory requirements and assess new product launch requirements and provide the regulatory information according to the needs of the business

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
  • have previous demonstrated experience in a similar capacity within a Regulatory Affairs function in a Medical Device related company with experience in Medical Device registrations.
  • have good organisational, time management, project management, and problem-solving skills.
  • are a self-starter, have a positive work attitude and can perform assigned tasks independently in a highly complex work environment
  • have excellent interpersonal skills with the ability to influence and negotiate with key stakeholders (both internal and external) and facilitate corrective action
  • can work under time pressure to meet deadlines and accept the need to work additional reasonable working hours to join in conference calls as required

What we can offer

  • competitive salary package
  • hybrid work arrangements
  • flexible working hours
  • the opportunity to work in a fast paced and fun environment

For a confidential discussion please contact Paul Wearing, HR Manager ANZ today on 0456 622 618 or via paul.wearing@cantel.com

 

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.  

Req ID:  32444
Job Category:  Regulatory Affairs

Victoria, VIC, AU, Vic 3189


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