Senior Regulatory Affairs Specialist - 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 Sr. Regulatory Affairs Specialist to join their innovative team in California. This role offers a unique opportunity to influence the regulatory landscape for groundbreaking medical devices, ensuring compliance with global standards while collaborating with diverse teams. The successful candidate will play a crucial role in guiding product submissions and maintaining regulatory approvals, contributing to the advancement of critical care solutions. With a focus on performance and employee well-being, this forward-thinking company provides competitive salaries and a comprehensive benefits package, making it an exciting place to grow your career.

Qualifications

• 5 years of experience in regulatory affairs, especially in medical devices.
• Strong knowledge of global regulations for Class II and III devices.

Responsibilities

• Support regulatory functions for new product development in critical care.
• Prepare documentation packages for submission to global regulatory agencies.

Skills

Regulatory Affairs

Problem-solving

Communication Skills

Organizational Skills

Analytical Skills

Leadership Skills

Education

Bachelor's Degree in related field

Tools

Regulatory Submission Software

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.

This position is based at our beautiful campus in Irvine, California.

How you will make an impact:

The Sr. Regulatory Affairs Specialist will support the execution of RA functions for new product development in critical care. Ensure compliance with global processes and regulations. Partner closely with CORE team, system engineers, software engineers, cybersecurity experts, marketing, clinical, Quality, & Compliance groups, and supply chain engineers to develop and lead the execution of the RA process. This is an exciting opportunity to take on the maintenance and completion of regulatory approvals and clearances of some of our revolutionary products.

• 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 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 document milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDEs, PMAs, annual reports, 510(k)s, STEDs and CE marking design dossiers and technical files).

• Monitor proposed and current global regulations and guidance; assess the impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite the approval process.

• Review labeling content, product and process changes, and product documentation to assure regulatory compliance, consistency, and accuracy.

What you will need (Required):

• Bachelor's Degree in related field

• 5 years’ experience of previous related experience

What else we look for (Preferred):

• Experience in preparing domestic and international product submissions

• Experience in the medical device industry, particularly with 510(k) submissions involving software

• Software experience, specifically with software as a medical device (SIMD) or software in a medical device

• 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.

• Excellent written and verbal communication skills including negotiating and relationship management skills

• Excellent problem-solving, organizational, analytical and critical thinking skills

• Full knowledge of new product development systems

• Good leadership skills and ability to influence change

• 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, 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.