Senior Regulatory Affairs Specialist

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This range is provided by i-Pharm Consulting. Your actual pay will be based on your skills and experience - talk with your recruiter to learn more.

A$120,000.00/yr - A$140,000.00/yr

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Are you a skilled Regulatory Affairs professional looking to join a global leader in the medical device industry? Whether you're an established Regulatory Affairs Lead or a Senior professional looking to take the next step into a lead role, this dynamic opportunity offers the chance to play a pivotal part in ensuring compliance and regulatory excellence for cutting-edge healthcare products. As the Regulatory Affairs Lead, you will take ownership of technical documentation, collaborate with cross-functional teams, and contribute to the success of innovative healthcare solutions.

Responsibilities:

• Own and maintain content of technical files for medical device products.
• Collaborate with the global Regulatory Affairs team to incorporate region-specific requirements into product documentation.
• Ensure regulatory compliance throughout the product lifecycle.
• Lead the regulatory aspects of product development, working closely with Product Development and Product Management teams.
• Manage and update technical files in line with product design and changes.
• Provide guidance on regulatory processes, offering internal training and promoting awareness across the organisation.
• Lead or participate in process improvement projects to streamline regulatory functions.
• Support post-market surveillance activities and assist with audits and regulatory agency reviews.
• Mentor junior members of the Regulatory Affairs team.

Skills:

• 3-5 years of experience in the medical device industry.
• Strong background in medical device development and regulatory compliance.
• Experience with regulatory submissions, change management, and risk management processes.
• Tertiary qualifications in Regulatory Affairs, Engineering, Science, or a related discipline.

Apply directly now, or send your updated CV to Ben Byrne at OR (04) 21776703

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Science
• Industries Medical Equipment Manufacturing

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