Lead Analyst, R&D Technical Writing - Individual Contributor

Job Title: Lead Analyst, R&D Technical Writing (Individual Contributor)Job Description

The Lead Analyst, R&D Technical Writing plays a key role in developing, coordinating, and delivering high-quality clinical and regulatory documentation for medical devices. This individual contributor position focuses on authoring clinical reports, summary documents, package inserts, and other regulatory documents, as well as overseeing electronic regulatory submissions. The role requires strong technical writing skills, deep understanding of regulatory requirements, and the ability to independently manage timelines and deliverables with minimal supervision.

Responsibilities

• Develop and complete clinical reports, summary documents, package inserts, and other technical and regulatory documents in a timely manner.

• Oversee the electronic regulatory submission process, ensuring accuracy, completeness, and compliance with applicable regulatory standards.

• Provide guidance and direction for the completion and development of clinical and pre-clinical documents, ensuring clarity, consistency, and scientific integrity.

• Recommend and help develop formats, templates, and guidelines for documentation to support consistency and efficiency across projects.

• Plan and manage timelines for all aspects of technical documents, proactively tracking progress and addressing issues to meet deadlines.

• Apply professional expertise and sound judgment to resolve issues related to document content, structure, and regulatory expectations.

• Review and analyze factual information to make evaluative judgments that improve document quality and regulatory readiness.

• Collaborate with cross-functional teams in clinical, regulatory, and R&D to gather necessary information and align on document strategy and content.

• Ensure that all documentation adheres to relevant regulatory requirements and internal quality standards for medical devices.

Essential Skills

• Minimum of a bachelor's degree (BS) or equivalent in a relevant discipline.

• At least 4 years of relevant medical writing and regulatory experience in the medical device industry.

• Proven experience preparing regulatory submissions and clinical reports for medical devices.

• Strong medical writing skills with the ability to create clear, concise, and scientifically accurate documents.

• Practical knowledge of regulatory affairs related to medical devices, including familiarity with FDA expectations.

• Experience working with regulatory documents such as IDE, 510(k), and PMA submissions.

• Ability to independently apply principles and concepts of the technical discipline to resolve issues as they arise.

• High attention to detail and accuracy in analyzing factual information and making evaluative judgments.

• Ability to work independently with minimal supervision in an individual contributor role.

• Strong organizational and time-management skills to effectively plan and manage document timelines.

Additional Skills & Qualifications

• Experience with clinical research documentation and processes.

• Background in R&D technical writing for medical devices.

• Familiarity with electronic regulatory submission systems and workflows.

• Understanding of regulatory requirements for clinical and pre-clinical documentation.

• Ability to contribute to the development of documentation formats, templates, and style guidelines.

• Strong collaboration and communication skills for working with clinical, regulatory, and technical stakeholders.

Work Environment

This position is 100% remote, offering flexibility to work from a home office or another suitable remote location. The role is highly focused on computer-based work, including document authoring, editing, and managing electronic regulatory submissions, and requires reliable internet access and a professional workspace that supports concentration and attention to detail. Collaboration with cross-functional teams occurs virtually through digital tools and communication platforms.

Job Type & Location

This is a Contract position based out of Portage, MI.

Pay and Benefits

The pay range for this position is $67.46 - $67.46/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on May 29, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.