1 Associate Regulatory Affairs Specialist – Coronary and Renal Denervation (hybrid) Job in Santa Rosa, CA
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Associate Regulatory Affairs Specialist – Coronary and Renal Denervation (hybrid)
$85k-111k (estimate)
Full Time | Medical Technology
5 Months Ago
Medtronic is Hiring an Associate Regulatory Affairs Specialist – Coronary and Renal Denervation (hybrid) Near Santa Rosa, CA
Associate Regulatory Affairs Specialist – Coronary and Renal Denervation (hybrid)
The Coronary and Renal Denervation (CRDN) division is focused on therapies that are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational Renal Denervation therapy, recently approved in the US and which has the potential to be a powerful tool in battling the global hypertension epidemic.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Preference is for this position to be based in Santa Rosa, CA. Candidates from California, Washington and Oregon will be considered.
Careers That Change Lives
The Associate Regulatory Affairs (RA) Specialist will provide general support within the Regulatory Affairs Department, assisting in areas of new product development and includes planning, executing and supporting global regulatory activities (e.g. submissions, STED/GSSD updates, change assessments) necessary to obtain and maintain regulatory approvals within US and International markets. This position ensures compliance with required global regulations and Medtronic policies for CRDN products and serves as a key team member and/or in a lead role on extended team(s).
A Day in the Life
- Provide support to the Geography RA who interact with regulatory authorities to assure timely new product introductions and continued product access
- Work on Product Development and Released Product Engineering teams, providing inputs to international regulatory strategy and execution
- Assist in keeping company informed of regulatory requirements in international markets
- Provides regulatory review of labeling, design changes, and specification changes as it relates to specific geographies
- Work with Geography RA teams to develop International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing
- Author Product Summary Technical Documentation (STED) or Global Submission Strategy Documentation. Supports Geography RA team to prepare international submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements
- Ensures relevant FDA and international import/export requirements are met, as required
- Supports international product demand planning and release activities
- Reviews Change Orders and assess regulatory impact of product changes on US and international regulatory strategy and submissions per standard procedures
- Supports post market regulatory compliance activities for US and international product approvals
- Develops and maintains regulatory affairs department procedures and process improvements
- Other duties as assigned or required
Must Have; Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelors degree required 0 years of experience required
- Medical Device industry experience
- Previous experience working across geographies/countries
- Strong Interpersonal and analytical skills
- Strong communication skills
- Attention to detail
- Strong Technical Writing Skills
Nice To Have
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 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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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) 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.
Salary Min: $55,600 Salary Max: $83,400
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$85k-111k (estimate)
POST DATE
12/07/2023
EXPIRATION DATE
05/13/2024
WEBSITE
medtronic.com
HEADQUARTERS
WASHINGTON, DC
SIZE
>50,000
FOUNDED
1949
TYPE
Public
CEO
PETER B SLONE
REVENUE
$3B - $5B
INDUSTRY
Medical Technology
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About Medtronic
Medtronic is a medical technology and services firm that manufactures devices and therapies to treat for chronic diseases.
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