Sr. Manager, Regulatory Affairs - Campbell - Shifamed

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

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

Responsible for US, EU and Japan Regulatory Affairs activities for a class III, breakthrough mechanical circulatory support system filed under PMA, EU Design Dossier(s) and Japanese Shonin. · Plans, structures and completes the writing of major regulatory submissions including US ...

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

We are seeking a Regulatory Affairs & Quality Specialist with experience in medical devices and international regulations. · ...

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 · ...

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

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

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. · ...

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

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 ...

We are looking for a highly skilled regulatory professional for a Regulatory Affairs Expert role within the Diagnostic Regulatory Affairs team.This is a brilliant and collaborative team of professionals that face exciting challenges and opportunities. · Develops and implements pr ...

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 · ...

We are hiring for a Regulatory Affairs Specialist to work on-site at our Santa Clara location.This new team member will combine knowledge of scientific regulatory business issues to enable products including combination products that are developed manufactured or distributed to m ...

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 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 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 complianc ...

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

We are searching for the best talent for a Director, This role will be based in Santa Clara, CA and will work a Flex/Hybrid schedule. Relocation assistance may be available on a case-by-case basis. · Develop global regulatory strategies to gain earliest possible, least burdensome ...