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Remote Regulatory Writing Jobs in Virginia (NOW HIRING)

Sr. Regulatory Affairs Specialist

Leesburg, VA ยท On-site +1

$100K - $105K/yr

Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required) Company: VB Spine Looking for a career ... Strong interpersonal, written, and verbal communication skills * Excellent organizational, planning ...

Strict adherence to all regulations (OFCCP and all other compliance standards set forth ... Strong written and verbal communication skills, including interacting regularly with the external ...

Excellent written and verbal communication skills. (High proficiency) * Knowledge of ICD-10-CM, ICD ... in accordance with regulatory and documentation standards and requirements, as well as all ...

Manager, Contracts (Remote)

Reston, VA ยท On-site +1

$92K - $123K/yr

... federal regulations * CFCM and/or CPCM Professional Skills: * Excellent oral and written ... Remote Office (US99)

Ensure compliance with contractual, regulatory, administrative, quality, onboarding, training, and ... Excellent written and verbal communication, customer engagement, team leadership, and collaboration ...

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Remote Regulatory Writing information

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.

What are the key skills and qualifications needed to thrive as a remote regulatory writer, and why are they important?

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What cities in Virginia are hiring for Remote Regulatory Writing jobs?

Cities in Virginia with the most Remote Regulatory Writing job openings:

Infographic showing various Remote Regulatory Writing job openings in Virginia as of August 2026, with employment types broken down into 100% Full Time. Highlights an 13% In-person, and 87% Remote job distribution.

Sr. Regulatory Affairs Specialist

VB Spine

Leesburg, VA โ€ข On-site, Remote

$100K - $105K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 19 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