Director Global Regulatory Affairs - San Jose

The Regulatory Affairs Specialist is a key partner to R&D, Quality, Manufacturing, and Marketing teams, · responsible for driving regulatory strategy and ensuring compliance with global medical device regulations. · Develop regulatory strategies for new product introductions and ...

The Regulatory Affairs intern will support regulatory activities for product registrations and maintenance of sustaining products in the US, Canada, EU, global regulatory assessment and international registrations, · Perform specific assigned regulatory tasks in support of US/EU/ ...

Under general supervision Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients Provides regulatory support for assigned projects. · ...

The Regulatory Affairs Specialist drives regulatory strategy and ensures compliance with global medical device regulations. · ...

The Regulatory Affairs Specialist is a key partner to R&D, Quality, Manufacturing, and Marketing teams, responsible for driving regulatory strategy and ensuring compliance with global medical device regulations. · ...

+ Job Overview · Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. · +Bachelor's Degree in Lifescience or related discipline. · At least ...

The Regulatory Affairs Specialist prepares and documents regulatory submissions to government agencies. They work on problems of diverse scope where analysis of situations or data requires a review of identifiable factors. · ...

· The Regulatory Affairs Specialist is responsible for managing regulatory submissions and government interactions related to products requiring regulatory approval. · ...

Seeking a Regulatory Affairs Associate to support international addendum labelling (IFUs, import labels, and country-specific labelling) for medical devices. · ...

The Senior Regulatory Affairs Specialist is responsible for managing and executing regulatory activities for Class III implantable medical devices that require governmental approval. · Prepare, author, and submit PMA supplements · ...

The Regulatory Affairs Specialist supports global regulatory strategy and execution for medical device products ensuring compliance with FDA and international regulations throughout the product lifecycle. · ...

We are seeking an experienced Regulatory Affairs Consultant to support sustaining activities for Class III medical devices. · Review, assess, and document regulatory impact of manufacturing, process, and validation changes · Support change control activities · ...

We are seeking a Regulatory Affairs & Quality Specialist with experience in medical devices and international regulations.This role involves handling regulatory submissions, interpreting letters from multiple countries, supporting cross-functional teams, and ensuring compliance w ...

The Regulatory Affairs Manager is responsible for monitoring regulatory requirements that impact HVAC products within the West Coast region. · ...

The Regulatory Affairs Specialist supports global regulatory strategy and execution for medical device products ensuring compliance with FDA and international regulations throughout the product lifecycle. · This role partners closely with R&D Quality Manufacturing and Clinical te ...

We are presently hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara CA location. Prepares robust regulatory applications to achieve departmental and organizational objectives. ...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. · ...

We are seeking an experienced Regulatory Affairs Consultant to support sustaining activities for Class III medical devices. · Review, assess, and document regulatory impact of manufacturing, process, · Solid understanding of FDA regulations · ...

+Job Summary · Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that ...

+The Regulatory Affairs Manager is responsible for monitoring regulatory and standards requirements that impact HVAC products and systems within the West Coast region. · + ...

This Regulatory Affairs Manager position is an on-site opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. · ...