Regulatory Affairs Manager - Medical Devices

Benefits

An 18-month contract for a Regulatory Affairs Manager has become available at global medical device company. Work in a collaborative environment where people do what they can to support each other. This role has flexible hybrid working arrangements and offers an attractive salary package.

About the company

A distinguished medical device company that manufactures and distributes a vast range of medical and surgical products across the globe. Established over 100 years ago, the company strives to offer innovative solutions to make a difference to patients lives.

About the opportunity

This position is to oversee all regulatory functions of the company. You will support the team to ensure the registration of new products and regulatory compliance of the company. You will bring your regulatory expertise to support the registration of new product introductions and correspondence with the TGA to ensure procedure packs meet all requirements.

Duties

• Ensure all products marketed, including procedure packs, in Australia and New Zealand meet the regulatory requirements of TGA, Medsafe and the Therapeutic Goods (Medical Devices) Regulations
• Develop and maintain technical files and design dossiers for components included in procedure packs where the company assumes responsibility as the Regulatory/Legal manufacturer
• Update Conformity Assessment Certification, Technical Files, and Declarations of Conformity
• Liaise with relevant government bodies, Australian businesses, and international partners from a regulatory perspective
• Approve promotional material and ensure all product claims are substantiated (BCCR process)
• Maintain records of regulatory submissions and approvals to provide to stakeholders when required
• Oversee product recalls in Australia and New Zealand as per regulatory guidelines
• Liaise with the global regulatory team to ensure compliance in accordance with company protocols
• Provide support to the team to determine and achieve performance objectives
• Maintain an excellent company culture by providing motivation and empowerment to the team
• Ensure the training and development of staff

Skills and Experience

• A minimum of bachelor's degree in a life sciences related discipline
• Extensive experience in Regulatory Affairs
• Experience in product registrations for both hospitals and retail highly desirable
• Excellent written and verbal communication skills
• Good computer and excel skills

How to Apply

Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.