Director, Regulatory Affairs

Director, Regulatory Affairs, Program Manager, Critical Care - This position can be office based/ hybrid in Irvine, CA or home-based/remote within the US

This fantastic career opportunity will allow you join an innovative and fast-paced regulatory affairs team within our critical care business unit at Edwards Lifesciences. Your experience and expertise will be vastly appreciated as you play a pivotal role in bringing new products to market and ensuring existing products remain in compliance.

As the Director of Regulatory Affairs, Program Manager, you will lead critical tasks as a regulatory affairs' subject matter expert for complex tasks within New Product Development. You will lead changing prioritization within assigned product line as needed, work directly with members of the regulatory affairs team as well as other functional areas. Ability to assess, strategize and communicate regulatory guidance to different stakeholders is a must!

Key Responsibilities:
Develop and plan multiple complex and/or advanced regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables.

Will include representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, 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.

Identify and evaluate complex and/or advanced regulatory affairs process improvements and/or course correction/alignment opportunities to accelerate route to market access in collaboration with key stakeholders.

Develop and plan strategies and contingency plans for projects, including those that are most complex and challenging.

Provide direction and guidance to project teams to execute complex and/or advanced regulatory affairs projects, initiatives and/or programs.

Will include preparation of documentation packages for submission to regulatory agencies.

Interact with regulatory agencies as part of submission review and on-site audit support.

Anticipate and advise on future regulatory trends and direction, and frequently recommend preemptive approaches for company regulatory compliance

Act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input and influence on the development of standards/regulations that affect the Medical Device industry

Review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy

Other incidental duties

Education and Experience:
Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry, Engineering) PLUS 12 years of previous related experience Required OR Master's Degree in Regulatory Affairs or related discipline PLUS 10 years of previous related experience Required

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

Experience in preparing domestic and international product submissions Strongly Preferred

Additional Skills:
Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives

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

Recognized as an expert in one or more areas with broad-based advanced knowledge within the organization

Expert knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices

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

Expert knowledge of new product development systems

Strong leadership skills and ability to influence change

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Represents leadership on projects within multiple areas, interfacing with project managers, regulatory affairs team and middle management

Consult in project setting within multiple regulatory affairs areas, interfacing with low to middle management

Provides regulatory affairs leadership to outsourcing partners on a task level, participates on small scale RFP

Adhere to all company rules and requirements (e.g., pandemic protocols, 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 $153,000 to $218,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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