Edwards Lifesciences
Senior Specialist, Regulatory Affairs
Edwards Lifesciences, Irvine, California, United States, 92713
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
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, 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 $105,000 to $124,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
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
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, 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 $105,000 to $124,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.