Regulatory Affairs Specialist - NV - Irvine, CA (Onsite)
Medtronic
Summary
In the Neurovascular Operating Unit, we develop therapies and technologies designed to advance stroke treatment and support patients across the continuum of care. The Regulatory Affairs function partners across the product lifecycle to help ensure our medical devices continue to meet U.S., European Union, and other applicable global regulatory requirements. This Regulatory Affairs Specialist position is based in Irvine, California and is an onsite role. Travel is expected to be less than 10%.
Job description
The Regulatory Affairs Specialist will support the Neurovascular product portfolio with a primary focus on sustaining regulatory activities and product changes. This role will provide regulatory guidance for product modifications, support U.S. and European regulatory submissions, maintain product technical documentation, and partner with Engineering, Quality, Clinical, Marketing, and other functions to maintain regulatory compliance throughout the product lifecycle.
Primary Responsibilities
- Provide regulatory strategy and guidance for product modifications and sustaining activities.
- Prepare U.S. Food and Drug Administration (FDA) Pre-Submissions and 510(k) submissions and technical documentation supporting European Union Medical Device Regulation (EU MDR) requirements.
- Assess product changes for regulatory impact and document regulatory filing or no-file decisions.
- Serve as a regulatory liaison with the FDA, Notified Bodies, and cross-functional project teams throughout the product lifecycle.
- Maintain regulatory and technical documentation to support applicable U.S., EU, and international requirements.
- Review promotional and advertising materials for regulatory compliance.
- Monitor changes to applicable regulations, guidance, and standards and update regulatory procedures and documentation as appropriate.
- Support internal and external audits and international regulatory submission activities as needed.
Required Qualifications
Bachelor's degree in Science or Engineering and 2+ years of medical device regulatory affairs experience OR advanced degree in Science or Engineering with 0+ years of medical device regulatory affairs experience.
Preferred Qualifications
- Experience supporting 510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA), or other global medical device submissions.
- Experience with FDA requirements, EU MDR, ISO 13485 quality management systems, and ISO 14971 medical device risk management.
- Experience developing or maintaining medical device regulatory or technical documentation.
- Regulatory Affairs Certification (RAC) or progress toward certification.
- Experience managing regulatory activities across multiple projects and cross-functional teams.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Requirements
- Bachelor's degree in Science or Engineering and 2+ years of medical device regulatory affairs experience OR advanced degree in Science or Engineering with 0+ years of medical device regulatory affairs experience
- Experience supporting 510(k), IDE, PMA, or other global medical device submissions
- Experience with FDA requirements, EU MDR, ISO 13485 quality management systems, and ISO 14971 medical device risk management
- Experience developing or maintaining medical device regulatory or technical documentation
- Regulatory Affairs Certification (RAC) or progress toward certification
- Experience managing regulatory activities across multiple projects and cross-functional teams
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- Incentive Plans
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Retirement Plan Supplement
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.