- Write, review, and edit technical documents for regulatory submissions in a format consistent with applicable guidance documents
- Prepare and manage Q-submissions for timely responses from the FDA
- Assist in regulatory submissions (510(k), PMA, and CE)
- Prepare and manage e-STAR regulatory submission requirements
- Maintain regulatory files such as 510(k)s, PMAs, Q-Submissions, and CE dossiers for EU
- Support preparation of labels and labeling documents for submissions
- Work with other departments and communicate regulatory submission requirements and track submission deliverables for completion as per the project timelines
- Provide support to the team with regulatory strategy analyses and options
- Monitor and maintain regulatory registrations, certifications and licenses, ensuring they are accurate and up-to-date
- Keep abreast of regulations / guidances to ensure compliance
- Support external regulatory agency audits, providing regulatory input to minimize or prevent potential findings of non-compliance
- Organize and maintain all regulatory related documents
- Comply with company's QMS
- Other duties as assigned
- A minimum of a Bachelor's degree in Science or related discipline of 4 - 5 years experience in IVD regulatory or similar
- Certification in regulatory affairs is a bonus
- Excellent understanding of regulations and strong analytical and problem-solving skills
- Excellent written and Verbal communication skills with the ability to listen, articulate and advocate
- Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
- Ability to communicate effectively with employees across multiple departments
- Proficient in Microsoft Office applications - MS Word, Excel, and Powerpoint
- Strong organizational skills and attention to detail, along with the ability to work on a number of projects with tight timelines
-
Regulatory Affairs Specialist
20 hours ago
Integrated Resources, Inc ( IRI ) San Diego, United StatesJob Title: Regulatory Affairs Specialist · Work Location: San Diego OR San Clemente · Duration: 6 Months · Shift- M-F (8am to 5pm) · Note: · Submission Authoring Experience (510(k) preferred). · EU MDR experience. · Medical Device (MD) Experience (Software as MD or Software in MD ...
-
Regulatory Affairs Specialist
2 weeks ago
Cypress HCM San Diego, United StatesRegulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clini ...
-
Regulatory Affairs Specialist
1 week ago
Cypress Hcm San Diego, United StatesRegulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinic ...
-
Regulatory Affairs Specialist
19 hours ago
Astrix Technology San Diego, United StatesRegulatory Affairs Specialist - Software · Regulatory Affairs · San Diego, CA, US · Pay Rate Low: 38 | Pay Rate High: 39 · + Added - 21/06/2024 · Apply for Job · Our Client specializes in IV therapy, offering a complete range of systems, software, solutions, and consumables ...
-
Regulatory Affairs Specialist
1 week ago
Cypress Human Capital Management, LLC San Diego, United StatesRegulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinic ...
-
Regulatory Affairs Specialist
2 days ago
JobsRUs San Diego, United StatesJob Description · Job is seeking to hire a Regulatory Affairs Specialist for our client in San Diego, CA · Benefits Available · Weekly Pay · $37.46/Hour · Shift:8a-5p · Description: · Position Summary · Provides regulatory support and expertise by developing global regulatory ...
-
Regulatory Affairs Specialist
8 hours ago
Aequor Technologies San Diego, United StatesUS Regulatory Affairs Lead · SCOPE OF RESPONSIBILITIES: · • He/She will be responsible for representing regulatory function to approve promotional material · • He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making worki ...
-
Regulatory Affairs Specialist
2 days ago
Conflux Systems San Diego, United StatesJob Description · Job DescriptionDescription: · Position Summary · Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of ...
-
Regulatory Affairs Specialist II
1 week ago
Tandem Diabetes San Diego, United StatesSupports Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. Responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet cor Regulatory Affairs, Regulator ...
-
Senior Regulatory Affairs Specialist
19 hours ago
Invivoscribe San Diego, United StatesJob Description · Job Description · Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best c ...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Genalyte San Diego, United StatesJob Description · Job Description Genalyte, Inc., a leader in innovative diagnostic solutions, is seeking a highly skilled and motivated Senior Regulatory Affairs Specialist to join our dynamic team. In this pivotal role, you will leverage your expertise to navigate complex regul ...
-
Senior Regulatory Affairs Specialist
2 weeks ago
INVIVOSCRIBE INC San Diego, United StatesJob Description · Job DescriptionInvivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer ...
-
Senior Regulatory Affairs Specialist
1 week ago
Genalyte San Diego, United StatesGenalyte, Inc., a leader in innovative diagnostic solutions, is seeking a highly skilled and motivated Senior Regulatory Affairs Specialist to join our dynamic team. In this pivotal role, you will leverage your expertise to navigate complex regulatory landscapes, ensuring our gro ...
-
Sr Regulatory Affairs Specialist
2 weeks ago
Dexcom San Diego, United StatesAbout Dexcom · Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transformi ...
-
Regulatory Affairs Specialist II
5 days ago
Tandem San Diego, United StatesGROW WITH US: · Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to "innovate every day," put "people first," and take ...
-
Philips San Diego, United StatesPrincipal Regulatory Affairs Specialist, Software (U.S. Hub based) · Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product is a clinical decision support software medical device (SaMD) that uses p ...
-
Public Affairs Specialist
1 month ago
Customs And Border Protection San Diego, United States Full timeYou will participate in policy-making meetings and conferences, serving as an advisor on issues related to identifying information that will further the Agency's mission and goals. You will also maintain working relationships with representatives of the media; Federal, state, and ...
-
Staff Regulatory Affairs Specialist, Infusion
2 weeks ago
BD San Diego, United StatesJob Description Summary · As Staff Regulatory Affairs Specialist, Infusion, you will be responsible for Regulatory Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution and management of ...
-
Staff Regulatory Affairs Specialist, Infusion
3 weeks ago
BD (Becton, Dickinson and Company) San Diego, United States**Job Description Summary** · As Staff Regulatory Affairs Specialist, Infusion, you will be responsible for Regulatory Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution and management ...
-
Staff Regulatory Affairs Specialist, Infusion
2 weeks ago
BD (Becton, Dickinson and Company) San Diego, United States**Job Description Summary** · As Staff Regulatory Affairs Specialist, Infusion, you will be responsible for Regulatory Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution and management ...
Regulatory Affairs Specialist - San Diego, United States - Genalyte
Description
Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory Affairs Specialist to join our team
ABOUT THE ROLE
The Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. This role will be responsible for preparing submission documents and work cross-functionally with other departments to ensure timely completion of deliverables related to regulatory submissions. This role will also be responsible for maintaining regulatory related documents.
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
These may include but are not limited to:
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
BENEFITS & STOCK OPTIONS
At Genalyte, we believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and flexible paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.
SALARY RANGE: $75,000 - $100,000
Offer decisions and base salary depend on a variety of factors including, but not limited to, an individual's skills, qualifications, business need and experience.
Powered by JazzHR
