Specialist, Regulatory Postmarket Compliance

2 weeks ago

Sydney, Australia ResMed Full time

The primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence and excellence in execution. Ensuring that systems and processes are established to enable ResMed to comply with multiple regulatory frameworks, in order to support the design, development and manufacture of products which meet our customer’s quality requirements. Working closely with all internal stakeholders and external regulators to achieve business goals.

**Summary**

The Specialist Regulatory Postmarket Compliance (hereafter "SRPC") will lead regulatory affairs strategy to be aligned with objectives of our post market products. As part of the Global Product Regulatory Affairs function, the SRPC will be leading a team of Regulatory professionals responsible for post market compliance. The SRPC will be leading strategic discussions with leaders and team members to define smart post market regulatory strategies for ResMed products and potential partnerships, and working collaboratively with Product Development, Global Product Management, Marketing, Quality, Regulatory and Commercial teams. The SRPC will drive global collaboration with all other Regulatory specializations, other internal stakeholders, and regulators to achieve company objectives. The SRPC will ensure the continued compliance and delivery of our products to the appropriate regulations and quality system with a continuous improvement mindset, educate stakeholders in post market regulatory intelligence.

**Let's talk about Responsibilities and Accountability**
- Plan and coordinate regulatory post market strategies.
- Represent Regulatory Affairs on selected post market cross-functional teams (XFT's).
- Develop and implement submissions to regulatory authorities such as FDA, TGA and Notified Body for post market projects.
- Analyse the scientific content of submissions to ensure they are accurate and soundly presented.
- Monitor the status of submissions and advise stakeholders of their progress.
- Monitor external standards: e.g., post market standards (ISO, IEC, etc.), European harmonized standards, FDA policies and guidance, national and international regulatory requirements, industry journals, etc.
- Monitor internal standards and act appropriately.
- Maintain an up-to-date knowledge on all regulatory matters and advise senior management of potentially significant changes to post market strategies.
- Manage the continuance of regulatory compliance (post market) of existing ResMed products in selected region(s).
- Ensure clinical trials are conducted in accordance with the best opportunity to achieve regulatory approval.
- Provide post market regulatory support (e.g., Medical Device Reporting) and guidance as required.
- Manage special projects as required.

**Let's talk about Job Environment**

ResMed’s products must comply with the regulatory requirements applicable to medical devices for the markets in which they are sold. This includes, but is not limited to, the Food and Drug Administration (FDA) in the United States of America, the relevant competent authorities in Europe and the Therapeutic Goods Administration (TGA) in Australia, as well as applicable international standards such as ISO 13485. ResMed products are marketed based on a reputation of high-quality standards for workmanship, performance and reliability.

**Let's talk about Qualifications and Experience**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Minimum
- Engineering or Science Degree
- Six (6) related experience with a medical manufacturer or equivalent combination of education and experience

Preferred
- Knowledge of EU MDR regulations
- Must be detail oriented & highly organized.
- Ability to work independently and exercise judgment with limited supervision.
- Must possess strong interpersonal communication skills.
- Ability to prioritize workload with limited supervision.
- Must demonstrate teamwork building skills in & outside department.
- Ability to exercise judgment.

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