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:

• Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Present alternatives for meeting regulatory requirements and resolve conflicts between those requirements and development issues, and/or reporting to management
• Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions
• Support external and internal audits. May interact with regulatory agencies as part of submission review and on-site audit support
• Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes 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. Work with global cross-functional teams
• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in scientific discipline (e.g., Pharmacy, Biology, Microbiology, Chemistry, Plus 3 years related experience
• Master's Degree in scientific discipline (e.g., Pharmacy, Biology, Microbiology, Chemistry, Plus 1 year related experience

What else we look for (Preferred):

• 3 years experience preparing domestic and international product submissions strongly preferred
• Prior exposure to global regulations relevant to medical devices, Class II and/or Class III devices strongly preferred
• Experience with US PMA Class III products and EU MDR strongly preferred
• Coursework, seminars, and/or other formal government and/or trade association training
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Strong written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• 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
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Knowledge of new product development
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Adhere to all company rules and requirements (e.g., Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 $105,000 (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.