Medical Writer

RQM+; Polska; Remote; PLN 60,000 - 90,000; Full time

Job summary

RQM+ in Poland is seeking a Medical Writer to develop Clinical, Scientific, and Regulatory documents for EU MDR, IVDR, US FDA, and other regulatory requirements for RQM+ clients. You will conduct literature reviews, write Clinical and Post Market regulatory documents, and analyze information from various sources.

You will collaborate with cross-functional teams to gather and interpret clinical and safety data, stay current with evolving global regulations, and ensure documents follow RQM+

Qualifications

• Residence in Poland is required.
• 0–2 years of medical writing experience.
• Bachelor's/Master's/PhD in a relevant field.
• Strong medical and technical writing skills.
• Familiarity with research software and databases (Endnote, PubMed).
• Excellent organizational skills and ability to manage multiple projects.

Responsibilities

• Assess clinical data for evidence of validity, performance, and safety.
• Prepare, write, edit, and review regulatory clinical reports (Clinical and Performance Evaluations, Clinical Study Reports).
• Perform literature searches for Safety/SotA and review findings.
• Collaborate with cross-functional teams to analyze and interpret data.
• Stay current with global regulations and guidance and communicate impact internally and to clients.
• Ensure documents conform to RQM+ procedures and guidelines.

Skills

Medical writing

Regulatory writing

Scientific writing

Attention to detail

MS Office

Independent work

Education

Bachelor’s / Master’s / Ph.D.

Tools

Endnote

PubMed

Job description

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don’t make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

Job Summary:

As Medical Writer, you will develop and create Clinical, Scientific, and Regulatory documents in accordance with RQM+ procedures, European Medical Device Regulation (EU MDR), In Vitro Medical Device (IVDR), US FDA, and other regulatory agency requirements for RQM+ clients. This includes conducting literature reviews, writing Clinical and Post Market regulatory documents, analysis of product complaints and trends, and analyzing information from various sources.

Primary Responsibilities:

• Assess all clinical data related to the medical device/IVD and evaluate if there is sufficient evidence to verify scientific validity, clinical performance and safety, and demonstrate conformity to the relevant regulatory standards.
• Prepare, write, edit, and review regulatory Clinical Regulatory Reports, such as:
• Clinical and Performance Evaluations
• Clinical Study Reports
• Perform literature searches for Safety and Performance and/or State of the Art (SotA) and review for specific medical devices.
• Collaborate with cross-functional teams to gather, analyze, and interpret clinical and safety data.
• Stay current, understanding existing and proposed global regulations and guidance associated with clinical research, and relay the impact of such regulations and guidance internally and with our clients.
• Ensure documents are produced in accordance with RQM+ procedures and internal & external guidelines (e.g., MEDDEV 2.7.1 Rev. 4, PRISMA 2020).
• Interact and collaborate with RQM+ clients.

Education/Work Experience/Requirements:

• Reside in Poland
• 0-2 years of experience
• Bachelor’s Degree, Master’s Degree, or Ph.D.
• Experience in medical writing in the healthcare industry or academia, or in a related area, such as quality, regulatory, clinical research, or product support.
• Strong medical and technical writing skills
• Familiarity with research software and databases, (e.g., Endnote, PubMed)
• Strong scientific writing skills with attention to detail.
• Ability to work independently as a self-starter, demonstrating initiative and accountability.
• Excellent organizational skills to manage multiple projects and meet strict timelines.
• Self-motivated individual with a lead by example approach that endorses the company’s core values and culture.
• Working understanding of the RQM+ business, organization roles and responsibilities, the internal quality system, and operating systems and how to effectively maneuver within each preferred.
• Scientific or technical background
• Strong analytical, diagnostic, consulting and problem-solving skills and ability to tailor solutions to meet the needs of clients.
• Strong desire for continuous learning.
• Strong oral and written communication skills, including presentation skills.
• Excellent interpersonal, communication and influencing skills and ability to work with clients and employees within the medical device industry.
• Advanced Microsoft Office skills with an ability to become familiar with company specific programs and software.
• Willingness to work a flexible schedule.
• Experience in research methodologies.

Behaviors: Approachability, Business Acumen, Career Ambition, Composure, Courage, Client Focus, Integrity, Interpersonal Savvy, Ability to Multi-task, Self-Motivation, Strong Communication Skills

Supervisory Responsibilities:

This position does not have supervisory responsibilities.

Work Environment/Physical Demands:

This is a remote position. The employee is expected to maintain a dedicated, distraction-free home workspace with reliable high-speed internet access. Core working hours are determined by role responsibilities, client expectations, and business needs.

These requirements reflect what's typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know — we're happy to discuss options.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

Job Opportunity Verification

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

Every candidate going through the interview process will participate in a voice and/or video interview.

Exercise caution with unsolicited job offers or requests for sensitive information.

We are committed to promoting equality of opportunity for all staff and job applicants. We aim to create a working environment in which all individuals can make best use of their skills, free from discrimination or harassment, and in which all decisions are based on merit.

Our selection for recruitment does not discriminate based on age, disability, gender reassignment, marital or civil partner status, pregnancy or maternity, race, color, nationality, ethnicity, ethnic or national origin, religion or belief, sex or sexual orientation or gender reassignment status (protected characteristics).