Associate Specialist, Regulatory Affairs Operations - Irvine

Make a meaningful difference to patients around the world. From design to production our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments Working in partnership with external government and regulato ...

The Post-Market Regulatory Affairs Specialist represents the Regulatory Affairs function and is responsible for knowledge of requirements and processes for maintaining a product in the clinical setting. · A strong candidate must have Medical Device IDE (clinical trial) experience ...

The Manager Clinical Affairs will be responsible for case planning for global clinical trials and collaborating with internal and external stakeholders on CRB process development, execution, and improvement. · ...

The World Affairs Council of Orange County is seeking a motivated Grant Writing & Fundraising Intern to support our mission of advancing global education, civic engagement, and international dialogue in Orange County. · ...

The Regulatory Affairs Specialist will ensure BaRupOn's pharmacy manufacturing and healthcare operations meet all applicable regulatory requirements. · ...

The Medical Affairs Analyst will be a key member of the Office of the Chief Medical Officer (CMO) and serve an important role in building MicroPort's unified medical and evidence infrastructure. · This is an ideal role for a scientifically trained, detail oriented, and articulate ...

The Program Coordinator for Fraternity & Sorority Life (FSL) is responsible for supporting and managing recognized Greek-lettered fraternities and sororities at Chapman University. · Serve as primary advisor to FSL Governing Councils and chapters. · Advise chapters on adherence t ...

Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre-, and post-market applications), query responses and correspondence tracking. Maintains regulatory information for competitive intelligence, l ...

· We are searching for a Director of Regulatory Affairs with deep expertise in invasive electromechanical medical devices and extensive experience preparing and submitting 510(k) notifications. · Leads the preparation, submission, and negotiation of 510(k) premarket notification ...

+ A large medical device company · is looking for a Regulatory Affairs Coordinator · to help with compliance activities.1+ years of experience in regulatory affairs · Strong experience in the life sciences industry · Bachelor's degree · ...

We are currently recruiting for a Medical Affairs Manager to support one or several product development projects within our EP's product portfolio while fostering strong, productive relationships with colleagues across the organization. · ...

+ Job summary: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, · where treatments are smarter and less invasive, · and solutions are personal. · ...

We are seeking an accomplished Senior Regulatory Affairs Specialist to support US and EU regulatory submissions and develop regulatory strategies. The successful candidate will have a strong understanding of US FDA and EU MDR regulations. · Support US and EU regulatory submission ...

The Fitness Center Assistant strives to create welcoming environments that contribute to the University by building community, · increasing the students' pride in their university, · and improving students' healthy sense of self. ...

We are fueled by innovation at the intersection of biology and technology, developing smarter treatments. We're passionate about improving heart recovery. Our team develops leading solutions for heart electrophysiology.Join us to join a proud heritage continually elevating standa ...

We are looking for a highly motivated Medical Affairs Clinical Specialist to be part of our Medical Affairs team in Johnson & Johnson MedTech - Neurovascular. · This role provides medical oversight, clinical direction and scientific expertise throughout study design, execution an ...

We are looking for a highly motivated Medical Affairs Clinical Specialist to serve as the clinical medical and scientific lead for clinical trials in the J&J MedTech Neurovascular portfolio. · ...

We are looking for a highly motivated and knowledgeable Associate Director - Medical Science Liaison (MSL) who specializes in cardiovascular medicine, · Support the development and implementation of strategic engagement plans to establish and maintain relationships with KOLs, · A ...

Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. · We partner with DirectEmployers to promote this job for J&J Family of Companies · ...

We're hiring a QARA Manager with hands-on medical device QA/RA experience to lead and harmonize our global Quality and Regulatory program. · This role is accountable for ensuring our QMS and regulatory compliance are effective across regions, supporting audits/certifications, gui ...