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Remote Medical Device Startup Jobs in Micronesia

Zoll Medical Corporation

... medical device industry, with proven experience in electro-mechanical products required ... For fully remote positions, compensation will comply with all applicable federal, state, and local ...

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Remote Medical Device Startup information

What are the key skills and qualifications needed to thrive at a remote medical device startup?

To thrive at a remote medical device startup, you need a strong background in biomedical engineering, product development, and regulatory compliance, often supported by relevant degrees or certifications. Familiarity with tools like CAD software, project management platforms, and FDA or ISO regulatory systems is typically required. Exceptional communication, self-motivation, and problem-solving skills are crucial for collaborating across remote teams and adapting to rapid changes. These skills and qualities ensure product innovation, regulatory success, and effective teamwork in a dynamic, distributed environment.

What are some common challenges faced by team members working remotely at a medical device startup?

Working remotely at a medical device startup often involves navigating time zone differences, maintaining clear communication across teams, and ensuring compliance with industry regulations without in-person oversight. Team members may find it challenging to collaborate on hands-on tasks, such as prototype development or device testing, which typically require coordination with local facilities or partners. However, startups usually foster a flexible, innovative environment that encourages proactive communication and creative problem-solving, making these challenges manageable for motivated professionals.

What is a remote medical device startup?

A remote medical device startup is a company that designs, develops, or sells medical devices while operating primarily through remote or virtual teams. Instead of having a traditional office-based setup, employees work from different locations, often collaborating online. These startups leverage digital tools to innovate in healthcare technology, sometimes creating devices for telemedicine or remote patient monitoring. Working remotely can help the company access a wider talent pool and reduce overhead costs. Many remote medical device startups focus on agile development and rapid prototyping to bring new solutions to the healthcare market.
What job categories do people searching Remote Medical Device Startup jobs in Micronesia look for? The top searched job categories for Remote Medical Device Startup jobs in Micronesia are:
Remote Medical Device Startup jobs near you

Senior Specialist, Regulatory Affairs

Zoll Medical Corporation

On-site, Remote

Full-time

Re-posted 3 days ago

Job description

Acute Care Technology

At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won't just have a job. You'll have a career-and a purpose.
Join our team. It's a great time to be a part of ZOLL!

Open to Hybrid / Remote
Job Summary
Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features.
Essential Functions

  • Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval.
  • Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
  • Provide strategic regional regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s).
  • Work with RA regional and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects.
  • Author and prepare submittals of IDEs, 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional device applications.
  • Work with management on risk assessment and regulatory compliance.
  • Support Cross-Functional NPI Project Teams and provide regulatory guidance.
  • Maintain current knowledge of regulations and guidance and collaborate with product teams on approvals and disseminate information and generate potential strategies with teams.
  • Lead, support, and coordinate with internal and external resources to meet audit and compliance requirements.
  • Support a culture of continuous improvement by promoting best practices, fostering innovation, and recognizing and celebrating achievements as well report on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts.


Required/Preferred Education and Experience

  • Bachelor's Degree required
  • Advanced Degree preferred
  • 5+ years of regulatory affairs experience preferably in the medical device industry, with proven experience in electro-mechanical products required
  • Regulatory Affairs Certification Preferred


Knowledge, Skills and Abilities

  • Experience building regulatory strategies to support successful regulatory affairs team.
  • Proven written and verbal communication skills to interface with a variety of stakeholders.
  • Ability to create action plans and project deliverables.
  • Supports team members in the preparation of suitable written responses to Regulatory Inquiries.
  • Experience in the electro cardiology or defibrillation/respiratory space preferred.


Travel Requirements

  • Requires travel (~5% - 10%)


Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Standing - Occasionally
  • Walking - Occasionally
  • Sitting - Constantly
  • Talking - Occasionally
  • Hearing - Occasionally
  • Repetitive Motions - Frequently


ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

The annual salary for this position is:

$101,600.00 to $152,400.00

This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

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