Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 3 days ago

Expert Regulatory Documentation Medical Devices/IVDs

EURES job mobility portal585,088 open roles

Where
Steyr-Kirchdorf, Austria
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowExpert Regulatory Documentation Medical Devices/IVDsEURES job mobility portal · Steyr-Kirchdorf, Austria

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on EURES job mobility portal's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

10.5% of postings close within 7 days. Measured by our own scanner across the market. EURES job mobility portal postings stay open a median of 9 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.3%3 days
  3. 10.5%7 days
  4. 15.9%14 days
  5. 34.1%30 days
This job: posted 3 days ago

EURES job mobility portal median: 9 days open

The posting

1 Expert Regulatory Documentation Medical Devices/IVDs Study Submission Management

* Prepare, compile, and process submissions to Ethics Committees (ECs) and Competent Authorities (CAs) for MD clinical investigations and IVD performance studies. * Manage initial submissions, amendments, annual reports, notifications, and end-of-study submissions. * Coordinate the collection of submission documents from cross-functional stakeholders. * Act as the primary contact for Ethics Committees and Competent Authorities regarding study submissions. * Track submission timelines and ensure timely completion of regulatory milestones. * Support country-specific submission strategies and regulatory pathways. * Coordinate responses to authority and ethics committee requests, questions, and deficiency letters. * Monitor applicable regulatory requirements and support continuous process improvements

Study Documentation & TMF Management

* Maintain GBO specific Document filing system for studies and study-specific TMF structures. * Ensure timely filing of mainly submission documentation packages * Support maintenance of TMF inspection readiness throughout the study lifecycle. * Support document version control and management of essential study documentation * Support internal audits, external audits, and regulatory inspections.

Study Information Database Management

* Establish, maintain, and continuously improve a centralized, searchable database for closed MD and IVD studies. * Ensure structured capture and maintenance of key study information, including study objectives, products, study designs, countries, participating sites, regulatory approvals, study outcomes, and final study documentation. * Define and maintain searchable metadata and indexing to enable efficient retrieval of historical study information and documents. * Generate study overviews, reports, and summaries to support regulatory, clinical, quality, and business functions. * Support cross-functional stakeholders by providing access to historical study information and archived study records for regulatory submissions, clinical evaluations, performance evaluations, audits, inspections, and other business needs. * Ensure completeness, accuracy, consistency, and long-term accessibility of study records and associated metadata. * Identify and implement opportunities for continuous improvement of study information management processes and tools.

Your profile * University degree in life sciences or an equivalent combination of education, training and work experience in clinical trials * Minimum 3-5 years of experience in clinical trials, preferred MD or IVD, as start up specialist, TMF manager, submission specialist, clinical trial assistant * Experience in setting up and maintaining a study Information Database is considered advantageous strong asset * Experience of submission in various European countries is considered a strong asset * Experience of submission of IVD and MD studies a strong asset * Familiarity with EUDAMED is considered advantageous * Effective and appropriate verbal and written communication with internal and external stakeholders, locally and globally * Ability to organize tasks, time, and priorities, ability to multi-task * Willingness to travel to our locations in Austria is required

Our offer We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 60.977,70 (minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment

KONTAKT:

Bitte melden Sie sich - im Zuge einer Personalvorauswahl - telefonisch beim Arbeitsmarktservice Kirchdorf bei:

Daniela Radner: 050 904 407 408.

Bitte geben Sie bei Ihrer Bewerbung diese Auftragsnummer an: ...

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against EURES job mobility portal's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on EURES job mobility portal's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    EURES job mobility portal's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.