Responsibilities may include the following and other duties may be assigned.
Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval.
Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.
The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter.
Develops and implements regulatory strategies to obtain timely product approvals form worldwide regulatory bodies.
Ensures regulatory submissions are accurately prepared and comply with regulatory approvals.
People working within region/country may also have the responsibilities that include:
Represents medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
Builds and maintains a strong network and close relationship with the various internal and external parties.
Leads execution for both local and global studies, manages clinical research projects over all of the medtronic therapies across multiple businesses.
Mentor, develop and coach staff on performance expectation and define objectives, provide leadership to staff, performance review and management, employee development towards departmental goals.
Establish operational plans, implement policies and strategies, budget management; strive for continuous improvement and consistent deliverables.
Communicate with internal and external customers and vendors regarding ongoing operations
Must have (minimum requirements): to be considered for this role, the minimum requirements must be evident on your resume.
Bachelor’s degree required with a minimum of 5 years of leading and managing clinical studies or advanced degree with a minimum of 3 years of leading and managing clinical studies experience
Nice to have (preferred qualifications):
Advance degree in science, clinical or medical field preferred.
Practical knowledge in leading and managing the execution of processes, projects and tactics in pain clinical research studies.
Prior experience in medical device industry is preferred.
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 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 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 stageLearn more about our benefits at benefits.medtronic.com
