Medical Writer – Clinical Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and coordinate Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs) for new product launches and ongoing product activities within the Dental Solutions business unit.

• Work collaboratively with cross-functional teams to gather, analyze, and evaluate clinical data in adherence to EU MDR and other global regulatory standards.

• Act as a subject matter expert in clinical evaluations to support both internal and external audits.

• Keep clinical evaluations updated throughout the entire lifecycle of medical devices.

• Assist in the creation of Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from management or supervisors.

• Adhere to corporate policies, procedures, and security standards while executing assigned tasks.

⛳️ Requirements

• A Bachelor’s degree or higher from an accredited institution, ideally in a scientific or technical field.

• A minimum of five (5) years of experience in the medical device sector.

• At least five (5) years of experience in medical writing or technical writing within a regulated industry, preferably aligned with EU MDR requirements.

• Strong scientific writing and communication abilities, with a knack for interpreting and presenting clinical data effectively.

• Experience in the dental field in a private, public, government, or military setting.

• Proven experience working on cross-functional teams within a global or regulatory framework.

• Familiarity with SSCP authoring and regulations for Class III/implantable medical devices in the EU.

• Exceptional attention to detail, time management, and organizational capabilities.

• Capacity to manage multiple intricate projects at the same time.

• Strategic thinking, critical thinking, reasoning, and interpretative skills are essential.

• Proficient in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.

• Experience using AI technologies to streamline workflows, automate tasks, and improve operational efficiency.

• Must possess legal authorization to work in the country of employment without sponsorship for employment visa status.

🏝️ Benefits

• Variable incentive pay, if eligible.

• Medical, Dental & Vision benefits.

• Health Savings Accounts.

• Health Care & Dependent Care Flexible Spending Accounts.

• Disability Benefits.

• Life Insurance.

• Voluntary Benefits.

• Paid Absences.

• Retirement Benefits.

• Up to 10% domestic travel may be included.