Senior Specialist, Regulatory Affairs - BD Advanced Patient Monitoring

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

Job summary

A leading medical technology company is seeking a Senior Regulatory Specialist in Irvine, CA. This role involves representing the regulatory function on product development teams, ensuring compliance with regulatory requirements, and preparing documentation for global submissions. The successful candidate will have a Bachelor's degree and at least five years of relevant experience, with a strong focus on communication and problem-solving skills. Competitive salaries and benefits are offered.

Benefits

Competitive salaries

Performance-based incentives

Wide variety of benefits programs

Qualifications

• Minimum five years of related experience.
• Experience in preparing domestic and international product submissions.

Responsibilities

• Represent regulatory function on product development teams.
• Prepare documentation packages for submission to regulatory agencies.
• Monitor global regulations and assess their impact on projects.

Skills

Communication

Problem Solving

Leadership

Analytical Thinking

Organizational Skills

Education

Bachelor's Degree in related field

Degree in scientific discipline

Tools

Microsoft Office Suite

Job description

Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such will become a part of the BD organization in the future. Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD 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, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions.
• Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy
• Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans
• Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE's, PMA's, annual reports, 510(k)'s, STED's and CE marking design dossiers and technical files)
• Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
• Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
• Other incidental duties

What you'll need (Required) :

• Bachelor's Degree in in related field
• A minimum of five years of related experience

What else we look for (Preferred) :

• Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry)
• Experience in preparing domestic and international product submissions
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Excellent written and verbal communication skills including negotiating and relationship management skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Full knowledge and understanding of global regulations relevant to medical devices, Class II and / or Class III devices
• Full knowledge and understanding of global regulatory requirements for new products or product changes.
• Full knowledge of new product development systems
• Good leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $90,000 to $127,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Create a job alert for this search

Senior Regulatory Specialist • Irvine, CA, US