Summary :
Seeking a Senior Regulatory Affairs Specialist with expertise in US and EU regulatory requirements, EU MDR regulation, and medical device regulatory submissions to sustain the current product portfolio.
Job Requirements :
Bachelor's degree in a relevant field.
3+ years of experience in regulatory affairs, specifically in the medical device industry.
In-depth knowledge of US and EU regulatory requirements for product modifications.
Experience with EU MDR Regulation & Remediation.
Familiarity with IDE and PMA Annual Reports, IDE Supplements, and PMA Supplements.
Experience with MDD and MDR STED updates.
Preferred Skills :
Proficiency in regulatory assessment of change orders with emphasis on US and EU requirements.
Experience with MAP Agile methodology.
Familiarity with ISO 13485, FDA Medical Devices Part 820, and medical device Good Documentation Practices.
Job Responsibilities :
Ensure compliance with US and EU regulatory requirements for the current product portfolio.
Partner with the international regulatory affairs group to support regulatory submissions.
Review and assess changes to products to ensure regulatory requirements are met.
Document "no file" decisions for regulatory changes.
Review promotional materials for regulatory compliance.
Maintain and update product technical documentation to ensure accuracy and compliance with current regulations.
Pay : 45-55
Pay Details : $45.00 to $55.00 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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