29 days ago

Regulatory Affairs Specialist


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About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

Job Mission

*Lead and coordinate U.S. or E.U. submissions for manufacturing process changes and negotiate their approval
*Provide expertise on regulatory requirements and define the RA Strategy for SMO projects.
*Support submission activities for other High Volume Facilities (MSO, MJC)
*Ensure partnership with Regulatory team and Agencies from geographies on Regulatory Affairs related activities.
*Ensure proper RA assessment instructions are maintained in the SMO Change management process as per applicable requirements

Regulatory Affairs Specialist

Description du poste:

Main Responsibilities

Regulatory Affairs:
*Evaluate US and EU Regulatory Affairs impact for manufacturing process changes related to CRHF devices under development or CRHF market released devices
*Perform Product Change Notifications (PCN) for CRHF products and coordinate geographies feedback
*Prepare U.S. and E.U. submissions for post-market manufacturing process and QMS changes to ensure timely approval for HVF
*Liaise with MDT RA or external parties on demands related to products submission preparation or SMO site certifications.
*Support audit / inspection readiness program as SME for Regulatory Affairs activities related to SMO changes and site complaint handling process.

Change Management:
*Ensure change management process alignment to BU requirements for RA assessment instructions
*Support the site "RA Coordinator" in a backup role.

Contribute and participate to a safety work environment, report any EHS risks and events (injuries, illness and accidents). Understand and enforce all Health and Safety policies, procedures and regulations

Profil recherché:

Job Experience & qualifications:

· Experience (5 years) in Medical Devices and/or Pharma industries

· Degree in engineering/scientific topic

· Medical Devices submissions knowledge

· Experience in Change Control process.

· Exposure to Compliance/Quality Systems Regulations (e.g. GMP's, process/document controls, CAPA, audits)

· Extensive communication skills:

- to operate in multicultural environment and cross-geographies teams

- to interact and influence at various levels within the organization

· Fluent in English and French

· Rigorous, detail oriented, proactive, flexible, results oriented and motivated by achievement

· Autonomous, contribute to others' success beyond own expertise and organization

· Decision making abilities

· Ability to deal with technical expertise level and to vulgarize for a broader audience

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