Senior Regulatory Specialist - Alameda
1 week ago

Job summary
We are seeking a Senior Regulatory Specialist to join our Quality and Regulatory Affairs team. This role will drive global regulatory strategies for our medical device and biologic products.
Responsibilities
- Develop and execute strategic regulatory plans for medical devices and combination products development programs across multiple global markets.
- Lead, prepare, author, and coordinate regulatory submissions including IDEs, 510(k)s , PMAs , technical files for CE marking ,and other international registrations .
Job description
, consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare.
Donec lacinia nisi nec odio ultricies imperdiet.
Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula.
Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit
, at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus.
Access all high-level positions and get the job of your dreams.
Similar jobs
Senior Staff Regulatory Affairs Specialist
3 weeks ago
We are looking for a Senior Staff Regulatory Affairs Specialist with Neurovascular / Neurointerventional Medical Devices Industry experience to join our team. · Prepare regulatory filing including 510(k), Q-submissions and 513(g). · Support labeling materials in all forms to foll ...
Sr. Staff Regulatory Affairs Specialist
10 hours ago
We re looking for a Sr Staff Regulatory Affairs Specialist with Neurovascular / Neurointerventional Medical Devices Industry experience who possesses a strong passion for their work and a robust drive to achieve success. · ...
Regulatory Affairs Specialist
1 month ago
The Regulatory Affairs Specialist oversees regulatory compliance for all products in accordance with local, national, and international regulations and customer requirements. · ...
Regulatory Specialist
4 days ago
Picarro, Inc. has an opportunity for a CEMS Regulatory Specialist that will assist the Environmental Solutions team with continuous emissions monitoring systems (CEMS) regulatory reporting and daily quality assurance review. · ...
Regulatory Specialist
4 days ago
Picarro Inc has an opportunity for CEMS Regulatory Specialist that will assist Environmental Solutions team with continuous emissions monitoring systems regulatory reporting daily quality assurance review. · ...
Sr. Staff Regulatory Affairs Specialist
1 month ago
Q'Apel is looking for a Sr. Staff Regulatory Affairs Specialist with Neurovascular / Neurointerventional Medical Devices Industry experience. · Prepare regulatory filing including 510(k), Q-submissions and 513(g). · Support labeling materials in all forms to follow US and foreign ...
Regulatory Specialist
2 weeks ago
The Blood & Marrow Transplantation and Cellular Therapy (BMT-CT) Division is seeking a Clinical Trials Regulatory Specialist II position to support a very active clinical trials faculty. · Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual report ...
Regulatory Specialist
1 month ago
The Blood & Marrow Transplantation and Cellular Therapy (BMT-CT) Division is seeking a Clinical Trials Regulatory Specialist II position to support a very active clinical trials faculty. · The position will anticipate and generate reports and prepare documents for submission as r ...
Regulatory Specialist
3 days ago
The Opportunity:Picarro has an opportunity for a CEMS Regulatory Specialist to assist the Industrial Solutions team with regulatory reporting for continuous emissions monitoring systems (CEMS) and daily quality assurance reviews. · ...
Regulatory Affairs Specialist
1 month ago
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. · ...
Regulatory Affairs Specialist
2 weeks ago
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 ...
Regulatory Affairs Specialist
1 month ago
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 ...
Regulatory Specialist
1 month ago
The Blood & Marrow Transplantation and Cellular Therapy (BMT-CT) Division is seeking a Clinical Trials Regulatory Specialist II position to support a very active clinical trials faculty. · Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual report ...
Regulatory Affairs Specialist
1 week ago
We are seeking a Regulatory Affairs Specialist for a 6-month temporary contract to support regulatory activities for medical devices. · This role combines scientific, regulatory, · and business knowledge to help ensure products meet applicable regulatory requirements across globa ...
Senior Regulatory Specialist
3 days ago
This Senior Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor in the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited s ...
Regulatory Operations Specialist
3 weeks ago
A rapidly growing medical device company is seeking a Regulatory Operations Specialist to support global regulatory activities across the product lifecycle. · ...
Regulatory Operations Specialist
3 weeks ago
A medical device company seeks a Regulatory Operations Specialist for global regulatory activities. · Manage regulatory documentation in electronic document management systems. · Support preparation and submission of regulatory filings. · ...
Regulatory Affairs Specialist
2 weeks ago
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. · ...
Regulatory Affairs Specialist
1 month ago
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. · ...
Regulatory Affairs Specialist
3 weeks ago
+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 ...
Regulatory Affairs Specialist
1 month ago
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 ...