Director of Regulatory Affairs
EnergyHubSalary not specified
Not SpecifiedCompensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical DevicesIndustries
Requirements
- Bachelor’s degree in Medical, Mechanical, Life Science or other healthcare related major
- 4-7 years experience in RA role in medical device and/or pharmaceutical industry
- Works independently with general supervision on larger, moderately complex projects/assignments
- Contributes to the completion of project milestones
- Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area
- Communicates primarily and frequently with internal contacts to share information, status, needs and issues
- Flexible working hours – required to work in US EST time zone
Responsibilities
- Liaison with OU Regulatory to ensure accurate application of processes and assignment of data attributes
- Conversion of Technical Documents to Global Submission Summary Documentation (GSSD)
- Creation of e-BOM structure in CAP Agile for GSSD
- Streamline Processes through use of Artificial Intelligence
- Monitors and remains in compliance with multiple Quality Management Systems
- Keeps abreast of regulatory procedures and changes
Skills
Regulatory Affairs
GSSD
e-BOM
CAP Agile
Artificial Intelligence
Quality Management Systems
Medtronic
Develops and manufactures medical devices and therapies
About Medtronic
Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.
Fridley, MinnesotaHeadquarters
1949Year Founded
$3.2MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Health Savings Account/Flexible Spending Account
Unlimited Paid Time Off
Paid Vacation
Paid Sick Leave
Paid Holidays
401(k) Retirement Plan
401(k) Company Match
Employee Stock Purchase Plan
Employee Assistance Program
Wellness Program
Risks
Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.
Spine biologics market growth may attract new entrants, increasing competition for Medtronic.
Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.
Differentiation
Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.
The company invests heavily in R&D to drive innovation in medical devices.
Medtronic offers comprehensive services, including training and technical support, enhancing product value.
Upsides
Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.
Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.
Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.
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