Senior Director, Regulatory Affairs - Hayward, CA

As a Regulatory Affairs Specialist at Sugar Bowl Bakery (SBB), you oversee regulatory compliance for all products in accordance with local national and international regulations and customer requirements. · ...

We are seeking a Regulatory Affairs Specialist for a 6-month temporary contract to support regulatory activities for medical devices. · Contribute to the preparation and support of regulatory submissions and filings for U.S. FDA and other global regulatory bodies. · Assess and do ...

· Who We Are · RefleXion is a privately held theranostic oncology company located in Hayward, CA, commercializing SCINTIX biology-guided radiotherapy, a novel therapy that uses a single radiotracer injection to turn cancer cells into real-time biological beacons to guide extern ...

Job summary · As a Regulatory Affairs Specialist at Sugar Bowl Bakery (SBB), you oversee regulatory compliance for all products in accordance with local, national and international regulations. ResponsibilitiesEnsure compliance with FDA regulationsReview and approve product label ...

The Senior Director of Regulatory Affairs provides regulatory leadership and develops regulatory strategies for products in development to support clinical trial application and marketing approvals. · Provides strong regulatory and scientific leadership to the overall development ...

This Regulatory Affairs Manager - APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division.We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. ...

Taiho Oncology is on a mission to improve the lives of patients with cancer and their families. They value their employees who work relentlessly to help execute this mission. · ...

We invite you to join our Regulatory Affairs team as an intern. This internship offers a unique opportunity for a motivated college student to gain hands-on experience in regulatory affairs/pharmaceutical industry by contributing to regulatory/FDA/health authority research projec ...

Taiho Oncology is on a mission to improve the lives of patients with cancer, their families, and caregivers. · ...

Taiho Oncology is on a mission to improve the lives of patients with cancer and their families through its "People first" approach. The company values its employees who work relentlessly to execute its mission. · Participate in literature review and research to support regulatory ...

We invite you to join Taiho Oncology as an intern in our Regulatory Affairs team. This internship offers a unique opportunity to gain hands-on experience in regulatory affairs/pharmaceutical industry by contributing to regulatory/FDA/health authority research projects within a dy ...

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

Lensa promotes jobs on behalf of its clients, including Abbott for this Regulatory Affairs Manager position in Alameda, CA. As a global healthcare leader, Abbott 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 · ...

This innovative patient-focused commercial-stage biopharmaceutical company based in China and US is seeking a Regulatory Affairs Director who can lead development implementation of regulatory strategy for key oncology asset. · ...

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 · ...

+Job summary · The Regulatory Affairs Specialist supports global regulatory activities for a diagnostic product portfolio under the guidance of senior regulatory staff. · +Foundational understanding of regulatory requirements for medical devices or diagnostics. · Familiarity with ...

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. · ...

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. · ...