Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring

Edwards Lifesciences; California (MO); On-site; USD 90,000 - 127,000; Full time

Job summary

An established industry player is seeking a Senior Specialist in Regulatory Affairs to join their Advanced Patient Monitoring unit. This role is vital for ensuring regulatory compliance for innovative medical devices. You will manage regulatory submissions, collaborate with cross-functional teams, and develop strategic plans for product approvals. The company values excellence and offers a supportive environment where your expertise will directly impact patient care. If you have a strong background in regulatory affairs and a passion for improving health outcomes, this opportunity is perfect for you.

Benefits

Competitive Salaries

Performance Incentives

Tailored Benefits

Qualifications

• 5+ years of relevant experience in regulatory affairs.
• Formal training in regulatory processes and compliance.

Responsibilities

• Manage regulatory approvals and clearances for assigned products.
• Prepare submission documentation for global regulatory agencies.

Skills

Regulatory Compliance

Communication Skills

Problem-Solving

Analytical Skills

Organizational Skills

Education

Bachelor's Degree in Biology

Bachelor's Degree in Microbiology

Bachelor's Degree in Chemistry

Tools

Microsoft Office Suite

Job description

Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring

Becton Dickinson (BD) recently acquired the Edwards Critical Care business. This position is part of the Critical Care division, which will become a separate business unit called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is a leading global medical technology company dedicated to improving health through medical discovery, diagnostics, and care delivery. Further details about this transition will be provided during the interview process. Learn more about BD at bd.com.

Responsibilities:

• Manage regulatory approvals and clearances for assigned products.
• Represent regulatory functions in manufacturing and product development teams, providing input on regulatory requirements and resolving compliance conflicts.
• Review and approve documentation such as protocols, reports, drawings, and procedures to ensure regulatory compliance.
• Develop regulatory strategic plans and provide guidance on regulatory requirements for strategic and contingency planning.
• Prepare and oversee submission documentation for global regulatory agencies, including GUDID submissions, and track milestones.
• Interact with regulatory agencies during submissions and audits.
• Monitor and assess the impact of global regulations and guidance on projects, proposing strategies to expedite approvals.
• Review labeling, product, and process documentation for compliance and accuracy.
• Perform other duties as required.

Minimum Requirements:

• Bachelor's Degree in a related scientific discipline (e.g., Biology, Microbiology, Chemistry).
• At least 5 years of relevant experience.
• Formal training through coursework, seminars, or trade associations.

Preferred Qualifications:

• Experience with domestic and international product submissions.
• Proficiency in Microsoft Office Suite.
• Excellent communication, negotiation, and relationship management skills.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Deep understanding of global regulations for medical devices, particularly Class II and III devices.
• Knowledge of new product development systems.
• Leadership skills and ability to influence change.
• Attention to detail and professionalism in interactions.
• Ability to manage priorities in a fast-paced environment and work collaboratively across departments.

We offer competitive salaries, performance incentives, and benefits tailored to our employees' diverse needs.

For California applicants, the salary range is $90,000 to $127,000, depending on experience and qualifications. Applications are accepted while this position is posted.