Job Description

Locations

• Australia, NSW, Sydney

Skills Required

• handling regulatory work for medical devicesintermediate
• other regulated markets a plusintermediate
• entity licensing for import/distribution of health productsintermediate
• ISO 13485intermediate
• software-based medical devicesintermediate

Required Qualifications

• Bachelor’s degree in a Life Sciences, Engineering, or related discipline. Equivalent experience will also be considered. (experience)
• Bachelor’s degree in a Life Sciences, Engineering, or related discipline. Equivalent experience will also be considered. (experience)
• 6 to 8 years’ regulatory experience in handling regulatory work for medical devices or pharmaceuticals specifically in the ANZ region, experience with other regulated markets a plus. (experience, 8 years)
• 6 to 8 years’ regulatory experience in handling regulatory work for medical devices or pharmaceuticals specifically in the ANZ region, experience with other regulated markets a plus. (experience, 8 years)
• Desirable experience with entity licensing for import/distribution of health products. (experience)
• Desirable experience with entity licensing for import/distribution of health products. (experience)
• Strong interpersonal communication skills in English (experience)
• Strong interpersonal communication skills in English (experience)
• Knowledge of ISO 13485, ISO 14971, design control requirements, post-market surveillance, and risk management principles. (experience)
• Knowledge of ISO 13485, ISO 14971, design control requirements, post-market surveillance, and risk management principles. (experience)
• Experience with software-based medical devices, digital health technologies, or connected healthcare products. (experience)
• Experience with software-based medical devices, digital health technologies, or connected healthcare products. (experience)
• Regulatory Affairs Certification (RAC) or progress toward RAC certification preferred. (certification)
• Regulatory Affairs Certification (RAC) or progress toward RAC certification preferred. (certification)
• Experience working in matrixed global organizations and influencing stakeholders without direct authority (experience)
• Experience working in matrixed global organizations and influencing stakeholders without direct authority (experience)
• Creative, detail oriented, resourceful, highly organized, and able to prioritize workload and work independently (experience)
• Creative, detail oriented, resourceful, highly organized, and able to prioritize workload and work independently (experience)
• Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant. (experience)

Responsibilities

• Participate in regional cross functional teams, by providing regulatory strategy, timelines, and deliverables; working closely with product development, clinical, marketing, and commercial functions to assure appropriate requirements are defined for the specific device/channel, including claims and target patient population within each market.
• Participate in regional cross functional teams, by providing regulatory strategy, timelines, and deliverables; working closely with product development, clinical, marketing, and commercial functions to assure appropriate requirements are defined for the specific device/channel, including claims and target patient population within each market.
• Manage the preparation and compilation (i.e., submission document creation, legalization/apostille) for premarket registrations for ANZ and Americas, as well as continuance of regulatory compliance (particularly post market) of existing ResMed products, including software as a medical device.
• Manage the preparation and compilation (i.e., submission document creation, legalization/apostille) for premarket registrations for ANZ and Americas, as well as continuance of regulatory compliance (particularly post market) of existing ResMed products, including software as a medical device.
• Control and maintain regulatory records, including, but not limited to: submission documentation, tracking of part number approval per country, establishment registrations, import for export, etc.
• Control and maintain regulatory records, including, but not limited to: submission documentation, tracking of part number approval per country, establishment registrations, import for export, etc.
• Support initiatives related to regional entity creations (including eCommerce).
• Support initiatives related to regional entity creations (including eCommerce).
• Ensure timely, professional, and proactive communications with: (1) internal customers to ensure transparency of the regulatory strategic plans, updates/changes, and impact to projected timeframes; (2) external customers to ensure applications are submitted to local health authorities consistent with regulatory strategic plan; and (3) health agencies/consultants to ensure adequate and appropriate information is provided as well as driving submissions to approval as effectively as possible.
• Ensure timely, professional, and proactive communications with: (1) internal customers to ensure transparency of the regulatory strategic plans, updates/changes, and impact to projected timeframes; (2) external customers to ensure applications are submitted to local health authorities consistent with regulatory strategic plan; and (3) health agencies/consultants to ensure adequate and appropriate information is provided as well as driving submissions to approval as effectively as possible.
• Monitor and maintain high level of awareness on external standards (technical publications, articles, and abstracts) that will influence our business through internal and external networks.
• Monitor and maintain high level of awareness on external standards (technical publications, articles, and abstracts) that will influence our business through internal and external networks.
• Accurately and timely share and recommended solutions to the global regulatory network on any potentially significant regulation or standard changes that will impact the business.
• Accurately and timely share and recommended solutions to the global regulatory network on any potentially significant regulation or standard changes that will impact the business.
• Demonstrate continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including ANZ and Americas country specific regulations, and policies applying to medical devices, global registration, technical writing, etc.
• Demonstrate continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including ANZ and Americas country specific regulations, and policies applying to medical devices, global registration, technical writing, etc.

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