Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- Staff Regulatory Affairs Specialist at BD representing Regulatory Affairs on compliance projects and product engineering. Coordinate regulatory submissions and support global regulatory strategies.
Responsibilities
- Represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on compliance projects
- 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
- Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies
- Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates
- 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.
Requirements
- Bachelor’s degree, preferably in a life sciences field
- Advanced degree preferred
- Minimum of 5 years Regulatory Affairs experience in medical devices, preferably sterile single-use disposable products
- Proven ability to resolve problems and make appropriate regulatory decisions
- Demonstrated success in the preparation and completion of 510(k) submissions
- Experience collaborating with FDA personnel during 510(k) review and meetings with the Agency
- Extensive knowledge of US medical device regulations including 21 CFR 820 - Quality System Regulation / design controls, consensus standards, and FDA guidance documents
- Current knowledge of European quality system standards and requirements under MDD and MDR
- Proficient in using Microsoft Outlook, Word, Excel, PowerPoint, and Adobe.
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
- Other Well-being Resources
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
- 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
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- 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
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age-related hormonal changes
- Leave Programs
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
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