Medical Writer - Poland

Rqmplus; Polska; Hybride; PLN 90 000 - 130 000; Plein temps

Résumé du poste

RQM+ is seeking a Medical Writer to develop Clinical, Regulatory, and Regulatory-technical documents for global medical device clients. The role emphasizes literature reviews, regulatory reporting, and collaboration with cross-functional teams to ensure high-quality, compliant submissions.

Requirements include residence in Poland, 0–2 years of experience, and a strong background in life sciences with excellent writing and communication skills.

Qualifications

• Reside in Poland.
• 0-2 years of experience in medical writing or related fields.
• Bachelor’s, Master’s or Ph.D. in life sciences or equivalent.
• Experience in medical writing within healthcare or academia.
• Strong medical and technical writing skills.
• Familiarity with Endnote and PubMed.
• Strong scientific writing with attention to detail.
• Ability to work independently and take initiative.
• Excellent organizational skills for multiple projects and tight deadlines.
• Willingness to align with RQM+ values and culture.

Responsabilités

• Develop and write Clinical, Regulatory, and Technical documents.
• Prepare and edit Clinical Regulatory Reports (Clinical Evaluations, Post Market Surveillance, CRRs).
• Perform literature searches for Safety and Performance data.
• Collaborate with cross-functional teams to analyze clinical data.
• Stay current with global regulations and guidance affecting regulatory writing.
• Ensure documents comply with RQM+ procedures and guidelines.
• Interact with clients to gather information and provide updates.

Connaissances

Medical writing

Regulatory knowledge

Attention to detail

Communication skills

Independent working

Formation

Bachelor’s/Master’s/PhD in life sciences

Outils

Endnote

PubMed

Description du poste

At RQM+, we know the success of our company and the success of our employees go hand in hand. That’s why we offer a compelling employee experience and are committed to helping yoube your best.

Find your next purpose-driven career move.

We take pride in fostering a rewarding culture by…

Supporting and encouraging one another personally and professionally.

Providing ethical and business-balanced solutions to our clients.

Improving lives through the work that we do and efforts in our communities.

Focusing on process and structure internally and for our clients, while being adaptable to individual business needs.

Nurturing a highly skilled, optimistic and passionate team of professionals.

Establishing a welcoming and inclusive environment.

Our Core Values

At RQM+, our core values shape how we work, collaborate, and contribute to the success of our clients — and ultimately, to improving patients’ lives.

Live by the golden rule

Maintain the highest level of integrity

“The caliber of people who work here is amazing. We have so many smart, kind, decent, and caring people, and that is so nice. From the minute I started, I felt sowelcomed and included. Great job on making sure you hire team players, people willing to collaborate and compromise and be just overall kind and decent people.”

Be courageous, proactive, and figure it out to achieve the highest level of success

“We get to work on projects that directly affect patients. I feel grateful that I can work with Tier 1 companies and see the product I’ve worked on ‘in the wild.’ I appreciate that my scientific training and experience are so well-suited to my work here and appreciated by clients.”

Laser focus on customer success

“I would recommend working at RQM+ becauseyou work with arange of clients, helping them achieve compliance. You help ensure safe and effective medical devices are placed on the market.”

Operate as a cohesive team… who likes to have fun

“The work/life balance is unmatchedand the ability to network with such a breadth of expertise and experience is an incredible asset.”

Improve all the time

“It’s acaring and balanced culturethat is remains driven to achieve greatness which gives confidence in the company and growth opportunities.”

Share concerns and follow up with a thoughtful solution

“I would recommend working at RQM+ because thework/life balance is unmatchedand the ability to network with such a breadth of expertise and experience is an incredible asset.”

Communicate… effectively and proactively

“I find meaningin working with my team to find technical solutions that help our clients and promote safe and effective medical devices. Great team.”

Live by the golden rule

“I cannot get over howkind and intelligent everyone is. I feel safe and heard every time I speak. I love the work life balance I have here.”

Maintain the highest level of integrity

“The caliber of people who work here is amazing. We have so many smart, kind, decent, and caring people, and that is so nice. From the minute I started, I felt sowelcomed and included. Great job on making sure you hire team players, people willing to collaborate and compromise and be just overall kind and decent people.”

Be courageous, proactive, and figure it out to achieve the highest level of success

“We get to work on projects that directly affect patients. I feel grateful that I can work with Tier 1 companies and see the product I’ve worked on ‘in the wild.’ I appreciate that my scientific training and experience are so well-suited to my work here and appreciated by clients.”

Laser focus on customer success

“I would recommend working at RQM+ becauseyou work with arange of clients, helping them achieve compliance. You help ensure safe and effective medical devices are placed on the market.”

Operate as a cohesive team… who likes to have fun

“The work/life balance is unmatchedand the ability to network with such a breadth of expertise and experience is an incredible asset.”

Improve all the time

“It’s acaring and balanced culturethat is remains driven to achieve greatness which gives confidence in the company and growth opportunities.”

Share concerns and follow up with a thoughtful solution

“I would recommend working at RQM+ because thework/life balance is unmatchedand the ability to network with such a breadth of expertise and experience is an incredible asset.”

Communicate… effectively and proactively

“I find meaningin working with my team to find technical solutions that help our clients and promote safe and effective medical devices. Great team.”

Live by the golden rule

“I cannot get over howkind and intelligent everyone is. I feel safe and heard every time I speak. I love the work life balance I have here.”

DEIB Statement

At RQM+ we promote equity for all by empowering our people to participate, learn, and excel. We embrace our individual talents and harness them to a common purpose. Together, we strive to create and sustain an inclusive and equitable environment where all employees feel a sense of belonging, respect, and acceptance. We create a culture that attracts and retains brilliant talents of all backgrounds and cultures while advancing global healthcare through MedTech innovation. Collectively, we help bring innovative, safe, and effective medical technology to the patients who need it most within the global communities we serve.

Join Our Team

Where Passion Meets Purpose

Working at RQM+ isn’t just a job—it’s a chance to make a real impact. Here, your career is more than a path forward; it’s a platform for growth, innovation, and purpose. Explore our open positions and discover how your next move can help shape the future of MedTech. Find purpose in every step.

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
  • Post Market Surveillance
  • 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).