Senior Director, Regulatory Affairs

Let's talk about Responsibilities

The Sr.
Director, Global Product RA shall have responsibility and authority to perform or delegate the performance of the following:


Strategic leadership:

Develop and execute global regulatory strategies to support ResMed' business objectives, ensuring regulatory compliance across diverse markets
Provide regulatory strategic, tactical and operational direction for new product development and product lifecycle support
Serve as a key regulatory advisor to Product executive leadership, driving decision-making aligned with regulatory and business goals
Form part of the global regulatory leadership team
Regulatory Operations:
Ensure the technical documentation is drawn up to manage premarket submissions primarily in the US/Canada, Australia, Europe but also registrations in all Countries where ResMed operates,
Lead regulatory product submissions/approval processes/maintenance/obsolescence related activities for major & reference markets (US/Canada, EU, AUS)
Provide strategic planning throughout the product lifecycle (DHF & change management, marketing claims/labelling, on-holds, post market actions) in collaboration with Product Quality teams
Collaborate with QA, PQA, Regional/Process and system/digitalization RA leaders to establish and improve processes (and related policies & procedures) to allow activities driving regulatory compliance to be performed efficiently, and in compliance with regulations & internal policies
Global Market access In close collaboration with the Regulatory Intelligence Sr Manager, monitor, track and manage impact assessment related to product regulations, guidance, standards ensuring readiness and adequate communication to internal stakeholders.
Act as a liaison with regulatory authorities with a primary focus on FDA, TGA & Notified Bodies, fostering positive relationships to expedite approvals and resolve issues effectively, and provide support for other regulators to Regional RA Leaders.
Represent the company in external regulatory forums and industry associations to influence policy development
Team & Cross Functional Collaboration Build, lead & mentor the high performing Global Product RA team (mainly US, AUS & SG) providing direction, training and professional development and maintaining adequate capabilities to ensure timely access to markets aligned with business strategy
Collaborate with internal stakeholders e.g.
Product Development, Product Marketing, Product Quality, Clinical, DSAIL, Legal, Regional & Systems RA leaders and others to align regulatory activities with product Lifecyle management and market needs.
Regulatory Compliance and Risk Management Ensure compliance with applicable international standards (e.g.
ISO 13485, IEC 62304, ISO 14971) including AI/ML regulatory frameworks
Establish and maintain robust regulatory processes to mitigate risks associated with product approvals and lifecycle changes while maximizing velocity
Leading internal discussions related to NBC, Strategy team ventures, Due Diligence and M&A and acquisition integration
Act as a regulatory PRRC
Position Specific Skills In-depth knowledge of medical device (& quality systems) regulations (FDA, EU Medical Device Regulation, Health Canada, Australia Therapeutic Goods Law, and International Standards
Understanding of AI/ML specific regulatory trends such as FDAs guidance and EU AI Act and relative impacts for designing, submitting and maintaining AI/ML products & solutions
Exceptional leadership, communication, and problem-solving skills
Ability to manage multiple priorities and lead in a matrixed, fast paced environment
Key Competencies Strategic thinking and vision
Global mindset with sensitivity to cultural and regional differences
Ability to anticipate and adapt to emerging regulatory challenges & to educate stakeholders accordingly
Commitment to fostering innovation within a compliant framework
Ability to resolve conflict situations, and engender both vertical and horizontal co-operation
Excellent written and oral communication and negotiating skills
Ability to develop, motivate and guide personnel with assessment and effective feedback on an ongoing basis
Work environment Hybrid or remote working options with regular travel to San Diego and other key company offices
Let's talk about Qualifications and Experience

Required 12+ years of experience in regulatory affairs within the medical device industry, including significant leadership roles.
Proven expertise in regulatory approval processes for hardware and software as a medical device (SAMD), preferably including AI/ML technologies
Strong track record of successful interactions with FDA and other global regulatory bodies
For the role as the Person Responsible for Regulatory Compliance, at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Preferred Bachelor Degree of Science or Engineering with considerable experience in Quality Management positions in a similarly regulated medical industry.

We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world's best talent.
We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members.
Employees scheduled to work 30 or more hours per week are eligible for benefits.
This position qualifies for the following benefits package:
comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.
Employees accrue three weeks Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.
Individual pay decisions are based on a variety of factors, such as the candidate's geographic work location, relevant qualifications, work experience, and skills.

At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.
A reasonable estimate of the current base range for this position is:
$ 208,000 -$ 313,000 Annual USD.

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!