Senior Specialist, Regulatory Affairs

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

How you'll make an impact:

• Complete and maintains regulatory approvals/clearances of heart valve replacement and repair devices

• Represent the Regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting requirements and resolving moderately complex conflicts between 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. Work with global cross-functional teams

• 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. 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., US FDA, EU notified bodies, Japan PMDA, Australia TGA, China NMPA other global regulatory agencies).

• 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 scientific discipline (e.g., Pharmacy, Biology, Microbiology, Chemistry, Plus  5 years related experience; including but not limited to providing regulatory expertise in US PMA Class III products, EU MDR, and working on product lifecycle management systems

• Master's Degree in scientific discipline (e.g., Pharmacy, Biology, Microbiology, Chemistry, Plus 3 years related experience; including but not limited to providing regulatory expertise in US PMA Class III products, EU MDR, and working on product lifecycle management systems

• Coursework, seminars, and/or other formal government and/or trade association training

• Work Location: This role requires on-site presence at our headquarters in Irvine, California.

What else we look for (Preferred):

• Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices strongly preferred 

• Experience with US PMA Class III products strongly preferred

• Experience with EU MDR (creating/updating technical documentation) strongly preferred

• Experience in product lifecycle management systems (Agile, Teamcenter etc.) strongly preferred

• Good leadership skills and ability to influence change

• Strict attention to detail and strong writing skills

• 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

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

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

• Proven expertise in Microsoft Office Suite including Word, PowerPoi