Job Description
Job Description
Job Summary: Seeking a Principal Regulatory Affairs Specialist with expertise in EU MDR related processes and strong project management skills.
Job Requirements:
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Must have a Bachelor's degree with a minimum of 7 years of experience in regulatory affairs or regulatory affairs program management
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Proficiency in Microsoft Excel and Power BI tools for data manipulation and visualization
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Experience with EU MDR Economic Operator requirements, EUDAMED, Article 22 procedure packs
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Ability to manage multiple projects simultaneously
Preferred Skills:
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Knowledgeable in OEM management
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Experience with medical devices compliance to new regulation under EU MDR
Job Responsibilities:
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Responsible for the implementation of EU MDR related processes
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Manage multiple projects and prioritize tasks daily to meet project schedules
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Develop understanding/experience with EU MDR regulation and the changes needed in medical devices to be compliant with new regulation
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Create or revise departmental procedures to improve operations or reflect changing regulatory requirements
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Monitor and improve tracking/control systems.
Pay: 56-75
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.
Pay Details: $56.00 to $75.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.