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Job details

Location
Sydney, New South Wales
Salary
Negotiable
Job Type
Full Time
Ref
BBBH36871_1626697425
Contact
Angela Barclay
Contact email
Email Angela
Contact phone
+61 2 88778743
Posted
8 days ago

Job details

Location
Sydney, New South Wales
Salary
Negotiable
Job Type
Full Time
Ref
BBBH36871_1626697425
Contact
Angela Barclay
Contact email
Email Angela
Contact phone
+61 2 88778743
Posted
8 days ago

Benefits

  • Develop, manage and mentor a team of regulatory affairs professionals
  • Assist the strategic vision and support business growth from regulatory affairs perspective
  • Working collaboratively with senior leaders across the business
  • Working across all medical device areas
  • Flexibility to work from home and in the office
  • Generous salary package and benefits on offer

About the company

The company is a global industry leader in medical technology known for its innovative approach and problem solving. The company has an expansive reach impacting the lives of tens of millions of patients each year.

About the opportunity

An opportunity exists for an experienced Regulatory Affairs Manager to work collaboratively with a broad portfolio of products across all classes of devices. Reporting to the Regulatory Affairs Director the role will ensure strategic alignment across the business and lead a team of regulatory professionals at varying levels in their career.

Duties

  • Lead, develop and mentor a regulatory team to ensure appropriate application of regulations and standards related to submission, preparation and commercialization, product and labelling compliance
  • Identify and influence approval activities, acting as a representative to influence, negotiate and support product submissions
  • Support short and long term strategic alignment between business functions
  • Develop relationships with key stakeholders and strategic partners nationally and internationally

Skills and Experience

  • Must have extensive regulatory affairs experience (~10 years)
  • Experience managing and developing teams (~5 years)
  • Expert knowledge of Australian Medical Device regulations and entire product lifecycle
  • Established relationships and experience in dealing with various divisions within the TGA
  • Understanding of EU MDR, implications for Australian regulatory environment
  • Experience covering a broad product portfolio is ideal
  • Experience leading internal and external audits
  • Proven track record of submissions
  • Experience in conformity assessments
  • Experience in a commercial organisation
  • Able to work independently
  • Strong interpersonal and communication skills

Culture

The company is committed to fostering a culture of innovation, diversity, integrity, compassion and global collaboration. Unique ideas are encouraged and rewarded.

How to Apply

Click apply or contact Angela Barclay, Associate Director on +61 2 8877 8743 for a confidential discussion.

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