Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring

Edwards Lifesciences; Irvine (CA); On-site; USD 90,000 - 127,000; Full time

Job summary

A leading medical technology company seeks a Senior Specialist in Regulatory Affairs for its Advanced Patient Monitoring division. The role involves ensuring compliance with regulatory requirements, preparing submissions, and guiding strategic planning. Candidates should have a Bachelor's degree and relevant experience, with strong communication and problem-solving skills. Competitive salary and benefits offered.

Qualifications

• At least five years of relevant experience.
• Degree in scientific disciplines like Biology, Microbiology, or Chemistry preferred.

Responsibilities

• Represent the regulatory function on manufacturing and product development teams.
• Prepare and oversee documentation for submissions to global regulatory agencies.
• Monitor global regulations and suggest strategies to expedite approvals.

Skills

Communication

Negotiation

Problem Solving

Organizational

Analytical

Critical Thinking

Teamwork

Education

Bachelor's Degree in a related field

Tools

Microsoft Office Suite

Job description

Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring

Type

Full time

Location

Job reference

Req-40183

Posted for

2 days ago

Becton Dickinson (BD) recently completed the acquisition of 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 committed to advancing health through innovation in medical discovery, diagnostics, and care delivery. If invited to interview, a recruiter will provide further details about this transition. Learn more at bd.com.

How you’ll make an impact:

• Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, present alternatives, and resolve conflicts, keeping management informed of options.
• Review and approve protocols, reports, drawings, procedures, and documentation to ensure compliance and accuracy.
• Guide strategic and contingency planning regarding regulatory requirements, including developing preliminary regulatory strategies.
• Prepare and oversee documentation for submissions to global regulatory agencies, assist with GUDID submissions, track timelines, and support interactions with agencies during reviews and audits.
• Monitor global regulations and guidance, assess their impact on projects, and suggest strategies to expedite approvals.
• Review labeling, product, and process change content to ensure regulatory compliance and consistency.
• Perform other incidental duties as assigned.

What you'll need (Required):

• Bachelor's Degree in a related field
• At least five years of relevant experience

What else we look for (Preferred):

• Degree in scientific disciplines like Biology, Microbiology, or Chemistry
• 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
• Comprehensive knowledge of global regulations for medical devices, especially Class II and III
• Understanding of global regulatory requirements for new products and changes
• Familiarity with 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
• Teamwork skills and experience collaborating across departments and with external stakeholders

We offer competitive salaries, performance-based incentives, and benefits tailored to support our employees and their families.

The base pay range in California is $90,000 to $127,000, depending on qualifications and experience. Applications are accepted while this position is posted.

About Edwards Lifesciences

Edwards Lifesciences is a global leader in structural heart innovations, dedicated to improving patient lives through breakthrough technologies and collaborations. Our culture is patient-focused, and we are committed to protecting patients and healthcare providers. All patient-facing roles require COVID-19 vaccination, with accommodations available for medical or religious exemptions where law permits.

For US Applicants Only

Qualified applicants with arrest or conviction records will be considered in accordance with applicable laws such as the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.