Job Description: Regulatory Affairs Specialist
A key member of the Regulatory Affairs Function, responsible for providing regulatory knowledge and supporting the business in meeting its objectives, as well as regional RA activities.
The role involves delivering product pre-market approval within specified timeframes, managing post-market vigilance, and maintaining all related regulatory activities to obtain necessary approvals while adhering to internal and external guidelines and procedures.
How You’ll Make an Impact :
* Provide regulatory support for products prior to launch.
* Manage regulatory pre-market activities, ensuring all submission requirements are met and timelines are adhered to, aligning plans with commercial objectives.
* Conduct ongoing post-market surveillance to identify and communicate regulatory changes or reforms that could impact the business.
* Perform post-market vigilance activities, including reporting product changes, adverse events, recalls, and issuing advisories.
* Maintain regulatory documentation and electronic databases.
* Monitor and update the RA library with external standards, references, and guidance documentation.
* Handle regulatory inquiries and requests from internal and external customers.
* Participate in inspections by regulatory authorities or agencies as needed.
* Act as the liaison with local authorities for registration and licensing activities.
* Collaborate with the global RA team for documentation and support.
* Represent the RA department in regional projects, acting as a subject matter expert to ensure regulatory deliverables are met.
* Set up and maintain LDS controls and licenses in SAP/GTS systems, monitor block and release statuses.
* Support compliance with local requirements such as importation and labeling (e.g., c-tick, RMC) in AU/NZ.
* Perform other regulatory duties as assigned by the manager.
* Support internal audit programs when necessary.
What You Bring :
* Bachelor of Science or equivalent qualification.
* Minimum of 5 years’ experience in Regulatory Affairs within the medical device, diagnostic, or healthcare sectors.
* Experience participating in internal audit programs.
* Strong analytical, communication, problem-solving, and computer skills.
* Knowledge of policies, practices, and procedures related to Regulatory Affairs.
* High attention to detail and ability to work independently.
* Excellent teamwork skills and ability to collaborate cross-functionally in a fast-paced environment.
* Willingness to travel domestically and internationally as needed.
Who We Are :
Bio-Rad has been advancing science and healthcare for over 70 years. As a global leader in life sciences, we develop and manufacture research and clinical diagnostic products that help improve lives worldwide. Recognized as a great place to work, we support our employees' growth and empower them to make impactful changes.
Benefits :
We offer comprehensive benefits including salary packaging options, extensive learning and development opportunities, education benefits, employee assistance programs, and insurance options, all aimed at supporting our employees' health, wealth, and wellbeing.
EEO Statement :
Bio-Rad is an Equal Opportunity Employer. We welcome candidates of all backgrounds, including people with disabilities, of all races, ethnicities, genders, ages, and orientations.
Agency Non-Solicitation: We do not accept resumes from agencies unless authorized by a Bio-Rad Recruiting Representative. Unsolicited resumes will not incur fees.
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Legal Entity : (AUS_3012)Bio-Rad Laboratories Pty Ltd
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