Regulatory Affairs Specialist, Corporate Regulatory

Edwards Lifesciences; Irvine (CA); Presencial; USD 74 000 - 104 000; Tempo integral

Resumo da oferta

Edwards Lifesciences is seeking a Regulatory Affairs professional to support process improvements and regulatory initiatives across multiple business units and international teams.

You will help monitor global regulatory changes, advise on strategies for expediting approvals, and assist on listings, registrations, and renewal processes. Strong communication and MS Office skills are essential, with knowledge of ISO 13485 preferred.

Qualificações

• Bachelor's degree in science with 3+ years regulatory affairs experience in a highly regulated industry OR Master's with 1+ year regulatory experience.
• Experience with global medical device regulations and ISO 13485 is preferred.

Responsabilidades

• Support implementation of Regulatory process improvement projects with stakeholders across business units and international counterparts.
• Support Regulatory Intelligence and Standards Management to identify regulatory changes impacting Edwards globally.
• Assist with strategies and contingency planning for worldwide Regulatory requirements and expediting approvals.
• Assist business unit regulatory affairs and functional teams with regulatory changes.
• Support FDA device listings, establishment registrations, and California renewal licenses as needed.
• Ensure adherence to regulatory requirements and assist supervisor as needed.

Conhecimentos

Regulatory affairs

Cross-functional communication

MS Office (Word, PowerPoint, Excel)

Formação académica

Bachelor's degree in science

Master's degree in science (optional)

Ferramentas

Regulatory databases

Descrição da oferta de emprego

How you will make an impact :

• Support the implementation of various Regulatory process improvement projects by working directly with key stakeholders in all business units as well as Edwards' international counterparts to accelerate market access routes and ensure compliance
• Support the Regulatory Intelligence and Standards Management programs to identify, observe and analyze Regulatory changes as early as possible that may impact Edwards' business globally
• Gather information to provide guidance on strategies and contingency planning with respect to worldwide Regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals
• Assist Business Unit Regulatory Affairs & Functional teams towards implementing Regulatory changes
• Assist on process improvement/remediation projects and responses from international affiliates
• Support FDA device listings, establishment registrations and the State of California Manufacturing Renewal Licenses, as needed
• Support compliance initiatives relating to Regulatory requirements
• Provide support to supervisor as needed

What You'll Need (Required):

• Bachelor's degree and minimum of (3) three years of Regulatory Affairs experience within a highly regulated industry OR Master's degree with at least (1) one year of Regulatory Affairs experience within a highly regulated industry; or equivalent work experience based on Edwards' criteria.

What Else We Look For (Preferred) :

• Degree in scientific discipline
• Medical Device, Pharma, or Biotechnology industry experience
• ISO 13485:2016 certification, coursework, seminars, and/or other formal government and/or trade association training is preferred
• Good knowledge and understanding of global Regulations relevant to medical devices, medium risk (i.e. Class II) and/or high risk (i.e. Class III) devices
• Good knowledge and understanding of global Regulatory requirements for new products or product changes
• Good knowledge of new product development systems
• Good written and verbal communication skills with people of various international backgrounds and good interpersonal relationship skills
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

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 (CA), the base pay range for this position is $74,000 to $104,000 (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.