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

How you will make an impact:

The Sr. Regulatory Affairs Specialist you will support the execution of RA functions for new product development product line in critical care.  Ensure compliance to 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 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.

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.