Regulatory Affairs Specialist - San Diego, United States - Genalyte

Genalyte

Verified Company

San Diego, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

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:

Write, review, and edit technical documents for regulatory submissions in a format consistent with applicable guidance documents
Prepare and manage Qsubmissions for timely responses from the FDA
Assist in regulatory submissions (510(k), PMA, and CE)
Prepare and manage eSTAR 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 uptodate
Keep abreast of regulations / guidances to ensure compliance
Support external regulatory agency audits, providing regulatory input to minimize or prevent potential findings of noncompliance
Organize and maintain all regulatory related documents
Comply with company's QMS
Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

A minimum of a Bachelor's degree in Science or related discipline of
5 years experience in IVD regulatory or similar
Certification in regulatory affairs is a bonus
Excellent understanding of regulations and strong analytical and problemsolving 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
Strong organizational skills and attention to detail, along with the ability to work on a number of projects with tight timelines

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.

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