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Remote Director Engineering Medical Device Jobs in Washington

VB Spine

Sr. Regulatory Affairs Specialist

Leesburg, VA · On-site +1

$100K - $105K/yr

Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required) Company: VB Spine Looking for a career ... Working knowledge of US and EU medical device regulations (international experience a plus)

Scout Space

Director of Engineering

Reston, VA · On-site +1

Background in space domain awareness (SDA), remote sensing, or on-orbit autonomy * Familiarity with ... Medical, Dental, Vision Insurance * 401k Matching * Health Savings Account, Flexible Spending ...

HiddenLayer

Director of Engineering

Washington, DC · On-site +1

Director of Engineering Remote [within the US] ABOUT THE ROLE: The Engineering Director is responsible for leading large-scale engineering initiatives across multiple teams, ensuring that the ...

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Remote Director Engineering Medical Device information

What are the key skills and qualifications needed to thrive as a remote director engineering medical device?

To thrive as a Remote Director of Engineering in Medical Devices, you need deep expertise in engineering principles, regulatory compliance (such as FDA and ISO 13485), and a relevant degree in engineering or a related field. Familiarity with product lifecycle management (PLM) systems, quality management software, and certifications like PMP or Six Sigma are highly valuable. Exceptional leadership, cross-functional communication, and strategic problem-solving skills help you effectively manage remote teams and complex projects. These capabilities ensure safe, innovative product development that complies with industry standards and drives organizational success.

What does a remote director engineering medical device do?

A Remote Director of Engineering in the medical device industry oversees engineering teams and projects related to the design, development, and manufacturing of medical devices, all while working remotely. They ensure that products meet regulatory standards, manage cross-functional teams, and drive innovation from concept through to production. This role requires strong leadership, technical expertise, and experience in the medical device field, as well as excellent communication skills to coordinate with remote teams and stakeholders.

What are some unique challenges faced by a remote director engineering medical device, and how can they be addressed?

A Remote Director of Engineering in the medical device field often navigates challenges such as ensuring effective collaboration across distributed teams, maintaining regulatory compliance, and overseeing complex product development cycles without onsite presence. To address these, it's important to implement robust project management tools, establish regular virtual check-ins, and foster a culture of clear documentation and accountability. Staying current with regulatory changes and leveraging digital quality management systems also help ensure that remote teams remain aligned with industry standards and deadlines.
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Remote Director Engineering Medical Device jobs near you

Sr. Regulatory Affairs Specialist

VB Spine

Leesburg, VA • On-site, Remote

$100K - $105K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 24 days ago

Job description

Senior Regulatory Affairs Specialist
Location: Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required)
Company: VB Spine
Looking for a career where your work truly matters? At VB Spine, you'll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We're the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets.
What You'll Do:
  • Participate on cross-functional product development teams to ensure US, EU, and international regulatory requirements are incorporated from the earliest stages
  • Author and manage regulatory submissions (including 510(k)s and technical documentation) to secure and maintain product approvals
  • Communicate FDA and other Health Authority feedback/correspondence to project teams and RA leadership
  • Support post-market submissions, including progress reports and annual reports
  • Conduct regulatory assessments for proposed product changes, manufacturing changes, and product transfers
  • Advise teams on appropriate regulatory pathways to market
  • Interface and coordinate directly with the FDA and other regulatory agencies on submissions, approvals, and compliance issues
  • Review and approve Engineering Change Notices (ECNs), labeling, collateral materials, and Instructions for Use (IFUs)
  • Maintain regulatory information systems, US product listings, and CE Mark Technical Files / Design Dossiers
  • Support internal and external audits and inspection readiness activities
  • Contribute to the development and maintenance of Regulatory Affairs SOPs and processes
  • Provide guidance and support to junior Regulatory Affairs Specialists and Associates
  • Participate in continuous improvement initiatives within the Regulatory Affairs department

What You Bring:
  • Bachelor's degree (B.S. or B.A.) in a scientific area preferred; RAC certification desired
  • Minimum 2+ years of experience in Regulatory Affairs within the FDA-regulated medical device industry
  • Hands-on experience preparing and submitting 510(k)s and/or Technical Documentation (required)
  • Working knowledge of US and EU medical device regulations (international experience a plus)
  • Strong interpersonal, written, and verbal communication skills
  • Excellent organizational, planning, and project management abilities
  • Ability to work effectively in a team environment and provide leadership on projects
  • Proficiency with personal computer systems and desktop office applications
  • Sound understanding of scientific and regulatory principles

Why VB Spine?
We believe in growing talent from within. At VB Spine, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance - positioning yourself for continued growth in a dynamic, mission-driven medical device company.
Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $100,000.00 - $105,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, regulatory expertise, and market conditions.
Benefits include:
  • Comprehensive health, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO) and holidays
  • Ongoing training and professional development opportunities
  • Opportunity to grow within a fast-paced, dynamic company

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