Senior Manager, Quality & Regulatory Affairs Transformation (healthcare)
We are looking for our future Senior Manager, Quality & Regulatory Affairs (Meddev) Transformation to join our global QARA Team.
The role can be based remotely in Ireland, the UK or Germany (Munich).
Let's talk about the Role:
The QARA Transformation team is responsible for facilitating large scale change throughout the business to facilitate future scale and future capabilities. This includes the expansion of manufacturing capabilities, the implementation of enterprise-wide facilities, systems and processes to enable efficiencies and future growth, and the integration of new businesses and acquisitions.
Through the development and execution of quality system tools and processes the transformation team assures large scale changes are executed with minimal disruption to the business using quality best practices in planning, requirements management, risk management, verification and validation and implementation.
The Sr. Project Manager, QARA Transformation assures appropriate tools are developed, implemented and leveraged to facilitate these activities and provides leadership and project management skills to these projects on behalf of the QARA teams.
Let’s talk about Responsibilities:
* Representing QARA in the execution of enterprise-wide transformation initiatives through project management cross functional collaboration.
* Focuses on the development and implementation of strategic and operational objectives that help achieve organizational mission with a focus on the assessment and execution of transformation programs as noted above.
* Implements organizational strategies through the effective direction and management of employees and resources.
* Regularly interacts with senior management on matters concerning several functional areas, divisions, and/or customers.
Let’s talk about Qualifications, Skills and Experience:
* Bachelor’s degree in Quality / Regulatory Affairs or equivalent. Master's preferred.
* Minimum of 10 years of related experience working on change and/or transformation programs from a QARA perspective.
* Excellent knowledge of EU/MDR & ISO 13485 standards.
* Ability to address issues with impact beyond own team based on knowledge of own function and related disciplines.
* Ability to analyse situations or data requiring evaluation of a different factors and understanding of current business trends.
* Experience defining and implementing standards to ensure consistent, high-quality project delivery.
* Strong problem-solving skills, with the ability to address complex issues that have broad organizational impact.
* Experience in managing and leading projects across multiple functions, with a deep understanding of cross-functional team dynamics.
* Exceptional communication and interpersonal skills, with the ability to influence stakeholders at all levels.
Additional information:
* At Resmed, all employees benefit from a bonus plan, the percentage of which depends on your position within the organisation.
* Working from home flexibility.
* You also have access to a referral bonus and to ResMed's preferred shareholding programme.
* Competitive benefits (Pension, Long-Term Illness Protection, Health Insurance...).
* Internal career opportunity - joining an international fast-paced and massively growing company.
* ResMed is an Equal Opportunity Employer.
OK, so what's next?
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!
About Us
At ResMed (NYSE: RMD, ASX: RMD) we pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives. Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, COPD and other chronic diseases. Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice. By enabling better care, we improve quality of life, reduce the impact of chronic disease and lower costs for consumers and healthcare systems in more than 140 countries. To learn more, visit ResMed.com and follow @ResMed.
ResMed Corporation is an equal opportunity employer and provides equal opportunity in employment for all qualified persons, without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
(US/Canada only) ResMed is an equal opportunity/affirmative action employer. ResMed is an E-Verify Employer. ResMed is a smoke-free workplace.
We are a 2024 Circle Back Initiative Employer – we commit to respond to every applicant!
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