We are looking for our future Advanced Regulatory Affairs Specialist to join our Regulatory team in Italy, GB or Sweden.
Let's talk about the role:
As part of the
EMEA Regulatory Affairs team
, participate to all regulatory activities related to the import and distribution of ResMed products in EMEA region from product registrations to follow-up of product changes and post-market activities. Work on European processes together with other functions to ensure the overall compliance of ResMed activities in EMEA. Work at the interface between the legal manufacturer and the country partners to ensure proper coordination.
Finally, as part of the implementation of the new European regulation on medical devices, activities related to the control/registration of products placed on the European market are planned.
Let's talk about key responsibilities:
* Collaborate to the evaluation of regulatory requirements, preparation, planning, submission, archiving and maintenance of product registrations in the European region & MENA countries to achieve timely approvals in accordance with commercial distribution and regulatory strategic plans.
* Collaborate and interact with local regulatory partners, legal manufacturers / production sites, other on-site functions to get information and documents needed for registrations.
* Verify the relevance of the information in order to prepare the registration file.
* Provide documentary support for the preparation of registrations: FSC, statement letters, formatting of documents.
* Review labelling to ensure compliance with relevant regional and national requirements.
* Analyze/Assess new local regulations related to product registrations, especially in the MEA region. Participate to regulatory watch.
* Support some regulatory requests received from the field (e.g. from customers, customs)
* Participate and contribute to the implementation of global or regional regulatory tools.
* Contribute to projects as a cross-functional member; represent the Regulatory function, provide regulatory assessments/inputs.
* Participate to economic operators' verifications activities.
Let's talk about qualifications and exeperience:
Required:
* Bachelor's Degree of Science or Engineering with a first experience in Regulatory Affairs positions in a similarly regulated medical industry.
* Knowledge of Medical device regulatory framework
* Fluent in English (read/spoken/written)
Preferred:
* At least 5 years of experience in Regulatory Affairs positions in a similarly regulated medical industry.
* Experience in medical device registration files preparation.
* Knowledge of Regulatory Information Management Systems.
* Very good organizational, administrative and writing skills.
* Good interpersonal/intercultural/communication skills.
* Autonomy/Capacity to work in remote management.
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
* Internal career opportunity - joining an international fast-pace and massively growing company
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
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