facebook

Job details

Location
Sydney
Salary
$130000 - $140000 per annum
Job Type
Full Time
Ref
BH-40443-5
Contact
Gemma Staddon
Contact email
Email Gemma
Contact phone
+612 8877 8776
Posted
24 days ago

Job details

Location
Sydney
Salary
$130000 - $140000 per annum
Job Type
Full Time
Ref
BH-40443-5
Contact
Gemma Staddon
Contact email
Email Gemma
Contact phone
+612 8877 8776
Posted
24 days ago
Benefits
• Work with a leading Healthcare company with a global presence
• Collaborative environment with a supportive team in place
• Hybrid Opportunity – Competitive salary package + bonus

About the Company
Our client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across Medical Devices.

About the Opportunity
As a Senior Regulatory Specialist, you will manage regulatory compliance for a diverse range of medical devices. Reporting to key stakeholders, you'll play a crucial role in ensuring our client's products meet regulatory standards, impacting the company's market presence positively. This role would suit a self-starter, someone who has experience working in Regulatory Affairs within medical devices, has a strong attention to detail and ability to build strong relationships cross functionally.
This is a hybrid role with the flexibility to work from home.

Duties
• Monitor and update the regulatory landscape, gathering intelligence, and maintaining the database.
• Collaborate with Regulatory Affairs Specialists to review and approve advertising and promotional materials.
• Support product releases by assisting in the preparation and submission of Product Release Authorization documentation.
• Ensure post-approval commitments to regulatory authorities are planned, tracked, and delivered on schedule..
• Participate in various projects and improvement process, including CAPA projects.
• Represent Regulatory operations in cross-functional interactions with other departments such as Supply Chain, Customer Support, Quality, and IT.
• Collaborate with cross-functional teams to integrate and meet regulatory requirements within Quality Systems.
• Participate in internal and external audits, providing regulatory expertise and follow-up support.
• Engage in interactions with regulatory agencies on defined matters
• Monitor and update regulatory databases.

Skills and Experience
• Experience in Regulatory Affairs with working knowledge of medical devices legislation
• Degree qualification in sciences to related discipline.
• Strong multitasking and detail orientation
• Strong communication skills
• Proactive and able to work in a fast passed environment.
• Strong attention to detail

Culture
Our client fosters an inclusive and collaborative culture, where every team member's voice is valued. Teamwork is at the heart of their success.

How to Apply
Click to apply or contact Gemma Staddon, Specialist Manager, at 02 8877 8776 for a confidential discussion.

Similar jobs

3 months ago

Regulatory Affairs

Regulatory Affairs Specialist

  • Sydney
  • $105000 - $110000 per annum

Benefits • Work with a leading Healthcare company with a global presence • Collaborative environment with a supportive team in place • Hybrid Opportunity – Competitive salary package + bonusAbout the CompanyOur client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with lead...

15 days ago

Regulatory Affairs

Regulatory Affairs Associate

  • Sydney
  • $110000 - $120000 per annum

Benefits• A role for an experienced Regulatory Affairs Associate.• Opportunity for career development and progression within the team.• Hybrid working & competitive salary package on offer.About the companyOur client is a leading regulatory consultancy - they are renowned locally and have a strong presence in the national market. Their e...

5 months ago

Regulatory Affairs

Regulatory Affairs Associate

  • Sydney
  • Competitive

BenefitsGreat role to join a collaborative Medical Device organisation.Exposure to diverse medical device portfolioHybrid working environment About the CompanyOur client is a leading Medical Device organisation with a strong presence in Australia, New Zealand, and Asia – they have a focus on quality and dedicated ...

3 months ago

Regulatory Affairs

Regulatory Affairs Associate

  • Sydney
  • Competitive Salary Package + Bonus

BenefitsOpportunity to work with cutting-edge medical device technologiesHybrid working arrangementsCompetitive salary and progression opportunitiesAbout the CompanyAn innovative medical device company at the forefront of healthcare solutions, dedicated to enhancing the well-being of patients worldwide.