Medtronic Santa Rosa CA United States
1 week ago
SENIOR REGULATORY AFFAIRS SPECIALIST - Renal Denervation (remote)
Coronary & Renal Denervation therapies are a vital component of the Medtronic Cardiovascular Portfolio. Our team is passionate about the patients we serve around the globe and the "second life" and improved health we can give to those with Coronary Artery Disease, High Blood Pressure, and other conditions. Renal denervation is an... innovative medical technology focused on the treatment of uncontrolled hypertension. Medtronic Renal Denervation utilizes a minimally invasive radiofrequency catheter paired with an RF generator to ablate the renal arteries with the intended purpose of reducing high blood pressure.
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.
Careers That Change Lives
The Senior Regulatory Affairs Specialist is responsible for developing and executing strategies for key global approvals to introduce novel Class II and III medical device Renal Denervation products to market, maintain existing products, provide advice on regulatory requirements, prepares submissions, and negotiates with regulatory agencies. The Sr. Specialist will actively work on a breakthrough device therapy while also having the opportunity to upskill and assist with advertising and promotion material review, training/mentoring of other regulatory affairs associates, and may provide consultation on projects of larger scale.
The right candidate will help develop the strategic direction and execution of regulatory filings such as FDA Pre-Submissions, PMDA Consultations, IDEs, PMAs, etc. This role is offered within a matrixed, collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence and a patient centered mindset. For the right regulatory professional, this role provides the opportunity to take their pre-market regulatory career to the next level at a leading, world-class medical device company. Candidates that will be successful in this role thrive in a dynamic and priority driven environment that requires creative strategies fostered by a culture that encourages new approaches that yield constructive, unconsidered insights.
A Day in the Life / Responsibilities:
• Acts as a team member on development projects to provide regulatory guidance and develop global regulatory strategies and timelines for key markets.
• Lead the preparation of US, Japan, and Canada regulatory submissions for new products and/or product changes as required to ensure timely approval for clinical studies, market release, and/or market expansion.
• Communicate and negotiate with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
• Support product development teams in interpreting and applying applicable standards, regulation, and guidance's for class III combination device balloon catheters systems.
• Asses global regulatory impact of product changes with a keen focus on quality and compliance at all times.
• Provide regulatory review and guidance for proposed product claims/labeling and advertising and promotional materials.
• Participates in inspections/audits either performed internally, by notified bodies, or by other international regulatory bodies.
• Assist regulatory department in the update, enhancement, and creation of internal policies and procedures.
• Provide mentorship, training, and support to other junior members of the department.
• Support assessment and recommendation of new and changing regulations, guidance documents, requirements as needed.
Must Have: Minimum Requirements
• Bachelor's degree in either the Science, Engineering, Healthcare, or related field
• Minimum 4 years of experience in medical device regulatory affairs
• Minimum 2 years of experience in medical device regulatory affairs, and an advanced degree
Nice to Have
• Preferred 3-5 years' experience in a medical device regulatory affairs environment with direct support of electric medical equipment or electrical medical system requiring knowledge of IEC 60601 and other global regulatory requirements for EMC.
• Direct experience authoring regulatory submissions for Class III/IV medical devices in the US, Japan, or EU (e.g., IDE, PMA, CTN, Shonin, Technical Documentation)
• In depth experience with FDA requirements, guidance documents, 510(k) submissions, Medical Device Regulation, ISO 14971, and ISO 13485
• Strong organizational skills and timeline management
• Strong oral and written communication skills
• Ability to manage multiple projects, work independently, and flex with changing priorities
• Experience with negotiations/interactions with regulatory agencies/health authorities
• Excellent analytical thinking and problem-solving skills
• Demonstrated ability to influence based on experience, facts, and data
• Highly motivated and team/results-oriented leader
• Ability to successfully work remotely (if applicable)
• Proficient in MS applications (Excel, Word, Outlook)
• Highly proficient in spoken and written English.
• Ability to travel 10% of the time
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: $86,000 Salary Max: $129,000
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities
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SENIOR REGULATORY AFFAIRS SPECIALIST - Renal Denervation (remote) Santa Rosa jobs
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