The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on compliance projects, product engineering, new product development, and other regulatory-related development initiatives and maintenance activities.
Requirements
- Coordinate, prepare, and complete premarket applications to the US FDA
- Act as liaison with FDA regarding product submissions
- Assess US regulatory requirements for proposed device modifications
- Prepare robust non-filing justifications for changes that do not require a 510(k) submission
- Support technical files for submission to European Notified Bodies for timely CE marking of new and modified products
- Represent RA and demonstrate leadership in complex product development teams
- Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies
- Support development and execution of global regulatory strategies
- Lead regulatory efforts required to align with new regulations and requirements
- Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance
- Prepare, submit, and maintain global regulatory submissions and registrations
- Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards
- Coordinate and respond to customer requests for product information
- May represent BD in relevant external trade organizations and regulatory standard's development
Benefits
- Annual Bonus
- Potential Discretionary LTI Bonus
- Health and Well-being Benefits
- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Dental coverage
- Vision coverage
- Hospital Care Insurance
- Critical Illness Insurance
- Accidental Injury Insurance
- Life and AD&D insurance
- Short-term disability coverage
- Long-term disability insurance
- Long-term care with life insurance
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
- Leave Programs
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
- Employee Assistance Program (EAP)
- Paid Parental Leave
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
- Other Life Balance Programs
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
