Regulatory Affairs Specialist
Location: You can be based out of our Middleton, WI site with hybrid flexibility
As a TEAMMATE:
The Regulatory Affairs Specialist specializes in understanding international regulatory requirements to support the proper design and development of medical devices. You could expect to work with product development teams to ensure that our products meet regulatory compliance standards for medical devices. In addition, you could expect to be responsible for maintaining product registrations in all international markets.
What you’ll get to do in this role:
· Assist with planning and execution of the EU Medical Device Regulation (MDR) projects in conjunction with site lead.
· Review and interpret documentation related to the introduction of the MDR.
· Update procedures, processes product specific documentation using the Natus change control procedure.
· Demonstrate highest level of professional regulatory discipline to ensure continued compliance to new or revised regulatory requirements
· Ensure compliance to MDR as well other medical device regulations and standards.
· Preparation and maintenance of Technical Files and Design Dossiers.
· Promote awareness of the MDR throughout the organization through regular training/briefing sessions.
· Integrate with corporate requirements and promote synergy/consistency with other sites.
· Monitor and communicate progress of MDR project to ensure compliance with internal quality objectives.
· Maintains and enhances cross-functional team relationships.
· Gain an understanding of global medical device regulations for specific jurisdictions, which may include such regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, FDA 21CFR Part 820, Canadian SOR-98-282, Australian Regulatory Guidelines for Medical Devices (ARGMD), Brazil ANVISA Medical Device Regulations, and the Japanese PMDA regulations, EU Medical Device Regulation (MDR) 2017/745.
· As appropriate, compile and generate CE mark Submissions / Significant Changes for submission to the Notified Body.
· Execute international registrations and submissions.
· Work with the Commercial Team and Natus Distributors, to ensure country specific registration activities are understood and appropriately addressed.
· Support Regulatory body audits, such as FDA, Notified Bodies, Competent Authorities, MDSAP and other global regulatory agencies.
· Travel: up to 10% on project need basis
What we are looking for:
RA Specialist 1 Qualifications
· Bachelor's degree from four-year college or university, or equivalent combination of education and experience
· Minimum 6 months' experience in Medical Device Regulatory Affairs, including specific knowledge of EU MDR, Medical Device Design Controls, and Risk Management Processes required.
· Working knowledge of FDA, Health Canada, and EU medical device regulations is required.
· Must be positive, a team player, transparent, and hold yourself and others accountable.
· Regulatory Affairs Certification (RAC) preferred.
· Experience with Electronic Medical Equipment preferred.
RA Specialist 2 Qualifications
· Bachelor's degree from four-year college or university, or equivalent combination of education and experience
· Minimum 1 years’ work experience in Medical Device Regulatory Affairs, including specific experience with EU MDR and following Device Design Controls and Risk Management Processes required.
· Demonstrated knowledge of FDA, Health Canada, and EU medical device regulations is required.
· Must be positive, a team player, transparent, and hold yourself and others accountable.
· Regulatory Affairs Certification (RAC) preferred.
· Experience with Electronic Medical Equipment preferred.
Compensation and Benefits: Along with a competitive salary and bonus structure, we offer a comprehensive benefit package: Healthcare Benefits that kick in Day 1, 401k match, 9 paid holidays, 4 weeks accrued PTO, and up to $5,000 tuition reimbursement annually.
We are PASSIONATE about:
Natus Medical Incorporated is recognized by healthcare providers globally as the source for solutions to screen, diagnose and treat disorders of the brain, neural pathways and sensory nervous system . Our vision is to deliver innovative and trusted solutions to advance the standard of care and improve patient outcomes and quality of life. Natus products are used in hospitals, clinics and laboratories worldwide.
EEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
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