Job description

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.

We're looking for a Technical Writer ideally from the Medical Device industry who can help create and maintain documentation for an ISO 13485 Quality Management System. In this role you will work with stakeholders to ensure that documentation is accurate, complaint and meets the needs of the users.

Primary Responsibilities

Create documentation Write manuals, guides, and standard operating procedures (SOPs) that explain technical processes

Updates documentation: Keep documentation up to date to reflect changes in processes and procedures

Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends

Work with subject matter experts, management, and employees to ensure documentation is accurate and meets needs

Ensure compliance. Make sure documentation meets industry standards, legal requirements, and guidelines

Improve processes. Work with the QA department to improve quality across deliverables

Requirements

Bachelor’s degree in a related field

Technical or engineering degree preferred

3- 7 years of experience

Medical Device experience preferred

Knowledge of ISO 13485 preferred

Strong writing skills

Ability to communicate quickly and clearly (written and verbal)

Attention to detail

Ability to write quality plans and procedures

Ability to balance quality compliance with business needs

Ability to work cross-functionally in a matrix organization

Strong understanding of quality system management

Behaviours

Action-Oriented, Analytical Mindset, Approachability, Business Acumen, Career Ambition, Composure, Courage, Customer Focus, Decision Quality, Detailed Oriented, Communication, Integrity & Trust, Interpersonal Savvy, Planning, Prioritizing, Time Management

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!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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.

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