Regulatory & Quality Wizard - Medical Device - (Freelance)
Who we are
is a pre-commercial clinical-stage MedTech company based in Zurich, Switzerland. In a dynamic startup environment, our team is developing a platform technology for implantable medical devices aimed at preventing post-surgical complications in implants (www.hylomorph-medical.com). Our pre-clinical study has proven excellent safety and tolerability of our devices, as well as a striking reduction of the inflammatory reaction and fibrotic encapsulation in pacemakers and breast implants. Our product consists in an easy-to-handle hydrogel pouch that tailor fits target implants and optimizes their interaction with the surrounding hosting tissue, finally re-establishing the health in the surgical pocket.
We closely collaborate with hospitals in Germany where our first-in-man clinical trial is currently ongoing, towards CE mark and FDA authorization.
We offer a stimulating and friendly entrepreneurial environment, with a team of 8 people in the heart of Zurich. You will experience all aspects of medical device life cycle management and startup development.
We are seeking a reference independent Regulatory & Quality Affair Expert who shall provide ad-hoc support to our team in ALL required actions in the preparation of our technical files towards CE-mark and FDA authorizations as well as ensure compliance of our QMS.
The primary responsibility of this position is to guarantee and underwrite company excellence in Regulatory and Quality matters, towards the flawless market approval of our products.
Responsibility of the Regulatory and Quality Wizard:
review selected parts of our technical documentation with an independent and unbiased eye
generate summaries of technical reports
act as a sparring partner to our Team members for confrontation on specific high-level as well as detailed regulatory and quality questions
review and amend technical plans and reports
act as Independent Reviewer for Design and Development according to ISO 13485 and 21 CFR 820.30 (e)
from time to time generate original written content
propose combination device related update of QMS
This position is part-time: you will accompany our Team throughout the execution of the full project, for a start-to-end planned duration of at least 3 years with variable workload depending on project phases. Detailed estimate on workload will be discussed and agreed on a quarterly or monthly base, in a timely manner for resource allocation.
10+ years of directly related industry experience working within similar positions and projects*
working knowledge of EU and US regulatory requirements*
originally developed as well as reviewed multiple technical files*
demonstrated experience and track-record*
experience working under QMS ISO 13485 and QSR all related, with particular reference to design & development, change control, supplier handling, CAPA, PMS, etc. procedures
lead/contribution/supervision to successful FDA and CE mark applications is a plus
*MUST HAVE: for class IIb or higher devices as well as combination products!
You will directly report to our Chief Regulatory and Quality Officer (CRQO) who will coordinate your assignments. You will work in close collaboration with the rest of our regulatory and quality team and interface with our operations and development team.
Who you are
You work as a Freelancer.
You hold a BSc or higher in Biological Sciences, Bioengineering, or an associated discipline.
10+ years-experience in similar positions within industry is required: combination products and FDA track-records are a big plus.
You understand the dynamics and requirements about medical device startups, have a keen eye for detail and see yourself as a flexible team-player with a “roll-up your sleeves” attitude.
Fluency in spoken and written English is a must (mother tongue is a plus).
You possess excellent written and verbal communication skills.
You work efficiently, are extremely organized, capable to coordinate and merge inputs from multiple co-workers and task-completion oriented.
You have an analytical and critical mindset, to proactively spot and fix flaws (problem solving), you have strong attention to details, yet you are pragmatic in searching and implementing the optimal solution.
You are outgoing and at ease outside your comfort zone. You enjoy a fair level of supervision but at the same time seek independence and self-accountability.
Place of work: remote – via use of Microsoft Office 365 package