Specialist, Regulatory Affairs

1 Edwards Way, Irvine, CA 92614, USA

Full-TimeDepends on ExperienceMid-LevelBachelors

Job Description

Represent regulatory affairs on product development and commercialization teams related to TMTT. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions. 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., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files). Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned. Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.

Where is this job?

This job is located at 1 Edwards Way, Irvine, CA 92614, USA

Job Qualifications

A minimum of five years of related experience is required
Experience preparing domestic and international product submissions is preferred.
Full knowledge and understanding of global regulatory requirements for new products or product changes
Must possess a strong working knowledge of US /EU regulations that affect Class III devices.

Required Skills

MS Word
MS PowerPoint
Time Management Skills
MS Excel skills
Data analysis and reporting skills
Oversee documentation

Soft Skills

Detail Oriented
Prioritizing skills
flexibility
Organizational skills
Verbal and Written Communication
Driven for excellence

Compensation

According to JobzMall, the average salary range for a Specialist, Regulatory Affairs in 1 Edwards Way, Irvine, CA 92614, USA is $80,000 - $105,000. This salary range may vary depending on the individual's experience, qualifications, and the company offering the job.

Additional Information

Edwards Lifesciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedAugust 2nd, 2021

Apply BeforeMay 22nd, 2025

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