Senior Regulatory Affairs Specialist

Join us in pioneering breakthroughs in healthcare.

For everyone.

Everywhere.

Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality.

We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

This is a role well suited to an ambitious professional, looking for the next step in their career.

This is a remote role.

As a Senior Regulatory Affairs Specialist, you will be responsible to:


* Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.


* Serve as a Regulatory Affairs subject matter expert, providing guidance to design control activities and new product development teams.


* Prepare, submit, and maintain Technical Files in compliance with applicable regulatory requirements and the Quality Management System (QMS).


* Collaborate with cross-functional teams to develop and maintain quality guidelines, procedures, and work instructions that support ongoing regulatory compliance.


* Independently or collaboratively lead and contribute to regulatory projects, ensuring timely execution and alignment with regulatory strategy.


* Provide training to internal stakeholders on country-specific regulatory requirements, as applicable.


* Independently or as part of a team, review promotional and labeling materials for regulatory compliance in accordance with country-specific requirements.


* Ensure audit- and inspection-ready documentation and provide guidance to cross-functional teams on appropriate regulatory documentation practices.


* Participate in internal and external audits, including quality system audits, design dossier reviews, and regulatory authority inspections, as applicable.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers:


* Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance Knowledge of point-of-care IVD products and applicable regulations for such products


* You have very good presentation skills, and you show team orientation and communication skills.


* Ensure cross-functional collaboration and cooperation.


* Excellent attention to details.


* Able to multi-task and work effectively in a dynamic environment.


* Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines.

Required skills to have for the success of this role:


* Bachelor's degree in scientific discipline


* Minimum of 4 years of experience in IVDs or Medical devices


* Skilled in Outlook, SharePoint, Adobe Acr...