We are seeking an enthusiastic, motivated Technical Writer to join our growing company. The Regulatory Affairs Office (RAO) Technical Writer will be responsible for conducting regulatory Regulatory Affairs research and writing quality documents to support the maintenance of the Regulatory Affairs system. This role will also provide guidance on regulatory requirements, international standards, policies, and procedures to internal teams and external partners. Additionally, the Technical Writer will have the opportunity to learn from and collaborate with our Quality, Production, Engineering, and Regulatory Affairs Staff.

This is an excellent opportunity for someone looking to establish themselves in the Medical Device industry. We offer competitive pay, a dynamic work environment, and opportunities for growth and development.

We offer a starting salary of $60k/year and a comprehensive benefits package, including paid time off, a company health plan, safety protocols, discounted aesthetic treatments, and more.

Please submit your resume and cover letter detailing your availability, skills, and qualifications for this; keep each to a single page.

Duties & Responsibilities Include:

• Conducting regulatory research and writing Quality Documents to support the clearance of Medical Devices. This may involve collaborating with internal teams and external partners, as well as staying up-to-date on industry standards and regulations.
• Providing guidance on regulatory requirements, policies, and procedures to internal teams and external partners. This may include developing and maintaining documentation, providing training, and answering questions as needed.
• Participating in the development of the regulatory strategy, plans, and reports for Medical Devices, including working closely with internal teams and external partners to support compliance and successful clearance.
• Contributing to the development of regulatory strategy, plans, and reports for Medical Devices, including working closely with internal teams and external partners to support compliance and successful clearance
• Reviewing and revising written work produced by others, as needed, in order to ensure accuracy, clarity, and alignment with established standards and requirements.
• Participating in training sessions and other learning opportunities offered by the company to gain knowledge about new Medical Devices, regulations, and industry standards.
• Maintaining a professional attitude, appearance, and work ethic at all times, and complying with company policies, procedures, and protocols. 

Overall, the Technical Writer will play an important role in supporting the clearance of Medical Devices by contributing to regulatory research and document development, providing guidance on regulatory requirements, and collaborating with internal teams and external partners to ensure compliance.

Base Qualifications:

• The ideal candidate should have:
• Bachelor's degree or equivalent in a related field (STEM, English, etc.)
• 1-3 years of experience in technical writing or a related field (College Classes
• Qualify, please list)
• Strong attention to detail and ability to manage multiple projects simultaneously.
• Excellent written and verbal communication skills
• Proficiency in document editing software i.e. MSWord, Open Office, etc.
• Communication, presentation, and interpersonal skills
• Attention to detail with organizational and coordination abilities
• Self-directed, the ability to work independently, and diligent
• Ability to function in a fast-paced and due-date structured environment
• Fluency in English is required. Other languages are a plus 

The following is a plus:

• Strong understanding of U.S. FDA and EU Medical Device regulatory requirements
• Knowledge of quality system requirements such as ISO 13485 and FDA 21 CFR Part 820
• Basic understanding of the rules and regulations of the USPTO

Working Conditions:

• The Technical Writer would work in an office environment that includes laboratory and manufacturing areas. Occasional travel may be required.
• The Technical Writer would work a standard workweek.

What You Can Expect From Medicreations:

• Salary: starting at $60,000/year
• Benefits: Paid time off + company health plan
• Free or heavily discounted aesthetic treatments
• An office and a continuous supply of coffee
• A diligent team to back you up and answer questions

Job Types: Full-time, Contract

Pay: Starts At $60,000.00 per year