Regulatory affairs specialist - coronary & renal denervation (remote)
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every dayIt’s no accident —we work hard to cultivate a workforce that reflects our patients and partnersWe 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 regulatory affairs specialist you will participate in the development of global pre-market regulatory strategies and be responsible for submissions leading to approval of new class iii and/ or iib (us/eu) products including but not limited to catheter-based technology to treat hypertension (renal denervation), coronary drug-eluting stents, and next-generation devices for percutaneous coronary interventionsAdditionally, the regulatory affairs specialist participates in developing strategies for worldwide medical device approvals to introduce new coronary and renal denervation products to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with regulatory agencies.
A day in the life
Prepare worldwide submissions for new products and their product changes as required to ensure timely approval for clinical studies and market release.
Review significant regulatory issues with management, as necessary, and negotiate submission issues with regulatory agencies.
Prepare regulatory strategies/plans and ensure compliance to worldwide requirements.
Provide ongoing support to project teams for regulatory issues and questions.
Find, interpret and apply regulations and guidance appropriately for situations.
Provide business and product information enabling development of strategies and requirements and communicate project status and information to the management teams.
Provide review of claims matrices and review advertising and promotion and training materials for new products.
Develops solutions to a variety of technical problems.
Actively participates problem solving discussions and recommends solutions.
Frequent use and application of technical or regulatory principles, theories and concepts.
Recognizes and communicates problems that may affect the business or regulatory objectives.
Provide regulatory support for currently marketed products as necessary to ensure ongoing complianceThis includes reviewing labeling, promotional materials, training materials, changes to existing devices and documentation.
Prepare submissions and reports for regulatory agencies as required.
Complete understanding and wide application of technical or regulatory principles, theories and concepts.
General knowledge of other related disciplines.
Negotiate directly with the fda or other regulatory bodies, as neededAll significant issues will be reviewed with management.
Participate in the development of general strategies, including how to interact more effectively with regulatory agencies and agency personnel, including submissions and audits.
Maintain regulatory affairs product files to support compliance with regulatory requirements.
Work under general supervision following established proceduresIndependently determines and develops strategic approach.
Frequent inter-organizational and outside customer contacts.
Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
Provide mentorship, training and support to other members of the department.
May travel: 10-20%
Other tasks, as required.
Must have: minimum qualifications
Bachelor’s degree in science, engineering, or healthcare related field.
Minmum 2 years of regulatory affairs experience or other relevant experience with a bachelor’s degree
Or 0 years of regulatory affairs experience or other relevant experience with an advanced degree
Nice to have
In depth experience with fda requirements, guidance documents, 510(k) submissions, medical device directive, iso 14971, iso 13485, iec 60601 and other global regulatory requirements and quality standards.
Knowledge of new medical device regulations (mdr).
Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., fda), and working with cross-functional project teams.
History of successful device submissions
Knowledge of glp/gcp requirements
Strong negotiation skills and written/oral communication skills
Strong organizational skills and time management skills
Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
Ability to work independently and under general direction only
Strong communication skill
About medtronic
Together, we can change healthcare worldwideAt medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterdayIt 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 teamLet’s work together to address universal healthcare needs and improve patients’ livesHelp 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 jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsFor office roles: while performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer, and communicate with peers and co-workersContact 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 valuesWe recognize their contributionsThey share in the success they help to createWe 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: benefits.medtronic.com
This position is eligible for a short-term incentive planLearn more about annual salary and medtronic incentive plan (mip) on page 6 here.
