Medtronic is looking to solve the problem of managing clinical studies and regulatory affairs to obtain timely product approvals and ensure compliance with regulatory requirements.
Requirements
- Minimum of 5 years of Clinical Research experience
- Or an advanced degree with 3 years of Clinical Research experience
- Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trials
- Experience in medical device clinical product trials and regulations
- Experience in clinical trial design, as well as managing clinical trials from start to finish
- Global clinical trial strategy and execution, and outcomes research study design
- Product development experience including global clinical strategy development
Responsibilities
- Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval.
- 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.
- Accountable for execution for both local and global studies, manages clinical research projects over all of the Medtronic therapies across multiple businesses.
- Research, prepare, and revise the Investigational Plan (study protocol, Instructions For Use (IFU), report of prior Investigations, bibliography, Case Report Forms (CRFs), etc.)
- Provides management review of relevant clinical documents.
- Supervise training of investigators, site staff, and Medtronic clinical staff.
Other
- Bachelor's degree required
- Leadership skills include strong communication, problem solving, quality focus, business integration acumen, and change management
- Demonstrated ability to work effectively globally on cross-functional teams
- Experience managing direct reports and leading clinical teams
- Cost-center/budget management experience
