Principal Regulatory Affairs Specialist (Northridge, CA)

Regulatory Affairs          ·          Northridge, California, United States            ·          Full time

Locations: Northridge, California, United States

Job ID: 230003NW

Job Description

Careers That Change Lives

As the Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.  Working with global Regulatory Affairs colleagues, you will ensure submissions are accurately prepared and comply with global regulations. 

This role focuses on products with hardware and/or interoperability with other devices or external networks. In this role, you will have primary RA responsibility for multiple Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world’s leading medical device company.

Diabetes Business:

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions is designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease. 

The preference is for the individual to reside near the Northridge, CA office but fully remote individuals can be considered. 

A Day in the Life

•  Partners with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new and marketed products. Work with RAS, engineers, and subject matter experts (SME) to resolve internal regulatory issues and questions/deficiencies from regulatory agencies.
• Define the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products
• Lead the preparation of regulatory submissions for new products and product changes, as required, to ensure timely approvals for market release. 
• Interact directly with FDA on projects/products at reviewer level. 
• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree and a minimum of 7 years of regulatory affairs experience within the healthcare industry (i.e., medical device, biotech, or pharma) 

OR

• Advanced degree and 5 years of regulatory affairs experience within the healthcare industry (i.e., medical device, biotech, or pharma)

Nice to Have

• Experience in Pre-Sub, IDE, 510(k), De Novo, PMA, RTR, CBE, 30DN, Annual Report submissions
•  Prior direct involvement with product development teams within medical devices, software, and cybersecurity
• Working knowledge of ISO 13485, ISO 14971, and IEC 62304 standards
• Good understanding of the product development process and design control through knowledge of US FDA and international medical device regulations
• Regulatory Affairs Certification (RAC)
• Must be able to write clear, understandable technical documents, i.e., regulatory documentation and scientific presentations
• Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, and quality assurance internally and external with respect to submissions, registrations, obtaining approval/clearance, and post marketing compliance
• Support products from initial concept through end-of-life phases
• Experience in assembling facts from various areas, analyzing data, and providing informed recommendations

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.

Physical Job Requirements 

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.  

Min Salary: $112,400
Max Salary: $168,400
Travel: Yes, < 25 % of the Time

Please click here to apply.