At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.Cardiac Ablation Solutions (CAS) is one of the Operating Units within the Cardiac portfolio at Medtronic. At CAS, we are developing next generation medical technologies that treat patients with abnormal heart rhythms. Our technologies save lives and improve the quality of living for millions of patients across the world by advancing innovation for the diagnosis and ablation of cardiac arrhythmias and enabling clinicians to perform procedures with superior outcomes.
The CAS business is projected to have solid growth, and this role will be critical in enabling our business to achieve our objectives to drive innovation, accelerate product introduction and lead the adoption of CAS driven therapies in the market. In this role as the Sr Director of Regulatory Affairs you will lead a team of regulatory affairs professionals for the Affera platform. This role requires a combination of deep regulatory experience, compliance expertise, technical aptitude, and business acumen. It will be critical that the candidate for this role be able to demonstrate an ability to work effectively with FDA and EU notified bodies on Class III products, implement regulatory strategies and maintain compliance. Ability to lead and motivate a team while building strong global relationships, both cross-functional and with global internal and external regulatory partners. Interpret regulatory requirements and effectively communicate internally with cross functional leadership.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities may include the following and other duties may be assigned.
Provide strategic regulatory guidance to business leadership.
Develops and implements strategies to achieve timely global commercialization of products in compliance with applicable regulations and standards.
Ensures comprehensive and compliant support of released products and support internal and external audits.
Develops and maintains ongoing relationships with global regulatory partners and regulatory authorities.
Establishes and maintains internal controls to ensure compliance as required by regulatory authorities.
Partners across the business and enterprise to continually improve processes related to regulatory activities.
Leads a strong, diverse regulatory affairs team with the competencies required to support a global portfolio in an evolving regulatory landscape.
Establish clear performance metrics, develop team capabilities, and implement strategies to attract, retain, and grow top talent in quality and regulatory disciplines
Demonstrate an ability to leverage learning and experience therapy-to-therapy in gaining approvals and maintaining approved status.
Review advertising and promotional materials
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s degree in scientific/technical field required; (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 15 years prior experience in regulatory affairs, clinical, quality and/or product development
With Masters or other advanced degree, minimum 13 years prior experience in regulatory affairs, clinical, quality and/or product development
Minimum of 10 years of managerial experience
Nice to Have
10+ years of Regulatory Affairs experience preferred, ideally in the cardiovascular space. Experience in other related functions such as clinical, quality or product development may be considered
Regulatory / Compliance Expertise
Extensive regulatory knowledge and experience across a wide variety of product classifications; including higher classification devices (i.e. Class III PMA, Class III EU).
Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities
Ability to apply experience to develop complex strategies
Ability to build and leverage expertise across the bread the of the Medtronic enterprise regulatory function(s)
Experience in impactful negotiations with regulatory agencies
Deep knowledge of pre- and post-market compliance requirements
Experience partnering across functions on advertising and promotional activities
Technical aptitude
Background in a scientific or other technical discipline
Excellent problem-solving skills and an ability to apply critical thinking
Knowledge of product development processes and tools
Application of significant working knowledge of other functional areas to identify and execute on opportunities for improvement
Business acumen
Significant experience as a member of senior business leadership teams
Demonstrated ability to partner to resolve complex business challenges
Ability to apply domain expertise and knowledge of regulatory environment to advise business on appropriate actions and future direction
Influences across functions and businesses to negotiate and gain cooperation on divergent objectives.
Competency in management of departmental budget
Communication / Leadership Skills
Demonstrated ability to develop and maintain strong, impactful relationships with global regulators
Ability to clearly articulate a complex strategy
Collaboration skills to partner with other functions to develop efficient approval strategies and resolve complex issues
Confidence and impact in presenting to diverse audiences
Ability to lead a team of experienced regulatory staff with responsibility for organizational structure and talent strategy ensuring skillsets evolve to meet the needs of the global regulatory landscape
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. 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.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
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.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.