Senior Regulatory Affairs Specialist – East Coast Preferred

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $89k - $119k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Cordis

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏭 Manufacturing

🏥 Healthcare

💊 Pharmaceuticals

Manufacturing • Healthcare • Pharmaceuticals

Cordis is a worldwide leader in the development and manufacturing of interventional cardiovascular technology with more than a 60-year history of pioneering products. The company specializes in high-quality and minimally-invasive cardiovascular products, maintaining operations in over 60 countries. As of August 2, 2021, Cordis operates as a standalone company, planning to invest $300 million to accelerate innovation within its diverse product portfolio.

📋 Description

• Assist, lead, and author documentation supporting high-quality regulatory submissions • Work with engineers, quality assurance, clinical, and other technical experts to develop compliance strategies • Prepare and manage global regulatory submissions for EU MDR, FDA IDE/PMA, LATAM, and APAC • Advise on regulatory strategies for development and marketed products • Lead process improvement initiatives to increase regulatory efficiency • Ensure ongoing compliance with QSR, ISO, and MDSAP requirements • Serve as regulatory representative on large projects and programs • Communicate regulatory requirements and regulatory impacts to project teams • Support global regulatory strategies for new and changing products • Interact directly with regulatory agencies • Prepare and submit PMAs, PMA-A/Ss, IDEs, Technical Files, and Change Notifications • Identify and develop Regulatory Affairs best practices • Support internal and external audits • Provide guidance to other regulatory team members • Support regulatory compliance activities across the business and corporation • Monitor new and changing regulatory and quality system requirements

🎯 Requirements

• Strong experience with PMA authorship and submissions • Bachelor’s degree in Science, Pharmacology, or related field • 5+ years of regulatory experience in medical device or pharma • Proven success with Class III device submissions and CE Marking • Experience with Class III Medical Devices • Experience with IDE, PMA, Design Dossier/Change Notifications, and Shonin Applications • Fluent in English • US work authorization required • Must not require sponsorship for a work-authorized visa • Strong written, organizational, verbal, and project management skills • Ability to work effectively in cross-functional teams • Ability to manage multiple competing priorities and programs with minimal oversight • Strong technical skills, critical thinking, and sound decision-making • Leadership or mentorship experience in regulatory affairs preferred • Global regulatory knowledge across multiple regions preferred • Experience with coronary/peripheral products preferred • Experience with combination products preferred

🏖️ Benefits

• Equal opportunity employment • Inclusive, equitable, and welcoming working and learning environments • Talent Community access to company news, career opportunities, and events

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume