Top 4 Biomedical engineering Jobs in Hudson, Fl

Medical Device Senior Regulatory Affairs Specialist
IsoAid, LLC —Port Richey, FL
- $69,244.73 - $99,305.49 a year
- Full-time
- Mid-level
- Office
- 3 years
- Health savings account
- Health insurance
Quick Apply

Discover related jobs

Based on your search for biomedical engineering jobs.

Medical Imaging Field Engineer - MR -Tampa, FL
Siemens Healthineers —Tampa, FL
To be eligible for employment, applicants must hold a valid driver’s license in the state they reside and may not have any prior DUI/DWI convictions or pending…
$78,380 - $107,778 a year
Biomedical Eng Tech II
BayCare —Clearwater, FL
Preferred Associates or Bachelors related field. Responsible for providing repair, calibration and maintenance services to medical treatment and diagnostic…

Show more related jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Biomedical Engineering Technician III
OhioHealth —Columbus, OH
AAMI certified and vendor certified for Life- support devices. Performs preventative maintenance PM and electrical safety tests of all types of clinical devices…
Biomedical Technician III
TRIMEDX —Columbus, OH
Valid driver’s license required; variable travel requirements depending on primary site that may require use of personal vehicle.

Show more jobs in cities nearby

I want to receive the latest job alert for biomedical engineering in hudson, fl

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

biomedical engineering jobs near hudson, fl

Regulatory Affairs Specialist jobs in Austin, TX

Regulatory Affairs Specialist jobs in Wallingford, CT

Regulatory Affairs Specialist jobs in Santa Ana, CA

Veterans Affairs jobs in Tuskegee, AL

Regulatory Affairs Specialist jobs in Paramus, NJ

Regulatory Compliance jobs in Chicago, IL

Veteran Affairs jobs in Lake City, FL

Medical Device Senior Regulatory Affairs Specialist

IsoAid, LLC
Port Richey, FL

Quick Apply

Job Details

Full-time
$69,244.73 - $99,305.49 a year

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Life insurance

Qualifications

ISO standards
E-filing platforms
Project management lifecycle
Bachelor's degree
Attention to detail
Organizational skills
Biomedical regulatory compliance
Managing projects
Productivity software
Quality audits
Technical Proficiency

Full Job Description

Overview
We are seeking a motivated and detail-oriented Medical Device Senior Regulatory Affairs Specialist with 3-5 years of hands-on experience to join our team. In this role, you will support the regulatory strategy and compliance activities for medical devices throughout the product lifecycle. You will play a key role in preparing and maintaining regulatory submissions, ensuring adherence to global standards, and facilitating timely market access while collaborating closely with cross-functional teams including R&D, Quality Assurance, Clinical, Operations and Marketing. High growth potential for the right candidate.

Key Responsibilities

Prepare, review, and submit regulatory filings to the FDA (510(k), PMA, De Novo, IDE) and international authorities (EU MDR/IVDR, Health Canada, etc.).
Maintain and update Technical Documentation, Design Dossiers, and regulatory files to ensure ongoing compliance.
Support product registrations, renewals, and post-market surveillance activities globally.
Conduct regulatory assessments for product changes, labeling, and promotional materials.
Collaborate with internal teams to ensure regulatory requirements are integrated into product development and lifecycle management.
Monitor and interpret evolving regulatory landscapes (FDA, EU, ISO 13485, etc.) and communicate impacts to the organization.
Assist in internal and external audits, including FDA inspections and Notified Body audits.
Prepare and maintain regulatory strategies, risk management files, and clinical evaluation reports.
Support complaint handling, vigilance reporting, and post-market surveillance activities.
Participate in cross-functional project teams to drive regulatory timelines and deliverables.

Qualifications and Experience

Education: Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.

Experience: 3-5 years of progressive experience in regulatory affairs specifically supporting medical devices (Class II and III preferred).

Strong working knowledge of U.S. FDA regulations (21 CFR Part 820, 510(k), QSR) and international standards (EU MDR 2017/745, ISO 13485, ISO 14971).

Experience with eCTD or electronic submissions is a plus.

RAC (Regulatory Affairs Certification) or similar credentials is highly desirable.

Required Skills and Competencies

Excellent written and verbal communication skills with the ability to prepare clear, concise regulatory documentation.
Strong analytical and problem-solving abilities with high attention to detail.
Proven ability to manage multiple projects and deadlines in a fast-paced environment.
Proficiency in Microsoft Office Suite and regulatory submission software/tools.
Ability to work independently and collaboratively within a team environment.
Strong organizational skills and project management experience.

Join us in advancing brachytherapy innovation! This role offers a vibrant environment where your expertise directly impacts patient safety and device efficacy worldwide. We value proactive problem-solvers who thrive in fast-paced settings and are passionate about improving health outcomes through cutting-edge radioactive technology.

Pay: $69,244.73 - $99,305.49 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

biomedical engineering jobs in hudson, fl

Medical Device Senior Regulatory Affairs Specialist

Discover related jobs

Explore jobs in cities nearby

I want to receive the latest job alert for biomedical engineering in hudson, fl

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected