Senior Specialist, Regulatory Affairs

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.

Throughout our history, Edwards has helped transform the way physicians monitor and take preventative measures for cardio patients. Our Critical Care business unit specializes in advanced hemodynamic monitoring solutions, including artificial intelligence algorithms to provide predictive readings to clinicians, helping them get patients home to their families faster. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

As the Senior Specialist, Regulatory Affairs, you will work with other functional areas as the regulatory expert to provide regulatory guidance throughout the R&D and clinical process, for each of our critical care devices in NPD stages. You will manage all Regulatory Affairs activities within the US, EU and respective country(is). Here you will work on some of the most innovative algorithm and software technologies, that will transform cardiovascular patient care.

You will make an impact by...

• Plan multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion within scope of project deliverables.

• Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing 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, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy.

• Provide direction and guidance to smaller project teams to execute tactical regulatory affairs projects and/or initiatives. Includes preparation and oversight of documentation packages for submission to regulatory agencies.

• Track timelines and documents for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support.

• Identify and evaluate regulatory affairs process improvements and/or course correction/course alignment opportunities.

• Develop strategies and contingency plans for projects

• Facilitate Edwards’ introduction of proposed and current global regulations and guidance, may advise on impact of such regulations on the company and may implement solutions.

• 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

• May review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy

What you'll need (Required):

• Bachelor's Degree in related discipline plus 5 years previous related experience OR

• Master's Degree or equivalent in related discipline plus 3 years related experience

• Experience with strong input/authoring 510(k)s strongly preferred

What else we look for (Preferred):

• Regulatory affairs experience with software devices

• Experience with product development

• Experience preparing domestic and international product submissions

• Basic knowledge and understanding of global regulatory requirements for new products or product changes

• Basic knowledge and understanding of domestic and global regulations relevant to Class II and/or Class III medical devices

Edwards is driven by a passion to help patients. We have an excellent company culture and truly invest in our people.

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 $86,000 to $121,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).