Offre d’emploi

POSTE : Regulatory affairs manager
CONTRAT : CDI
LIEU : Limoges (87) ou télétravail
ORGANISME : Optim'Care

Contract type : permanent
Starting date : ASAP
Localization : Limoges or remote with one day a week in Limoges.

The company:

Optim’Care is a startup created in May 2018.

We put digital solution at the service of a better life for transplant patients.

Our first platform allows doctors to build fully personalized telemonitoring.

We’re on a mission to provide digital tools to build personalized monitoring for patients in order to improve their health and help them live better with their pathology.

New solutions and services are currently under development.

The company is in early stages but is already expanding worldwide. Joining us now means building the roots of a company focused on improving peoples’ life quality.

Missions:

As regulatory affairs manager, you are responsible for product and company compliance with applicable regulations and depending on your profile, you also play a role in market strategy definition and implementation.

Your tasks:

  • Advise the internal team on regulatory and legal aspects before the design of a new functionality and before and after its marketing.
  • Regulatory framework analysis and strategy.
  • Implementation of documentation and activities to ensure company regulatory compliance.
  • Point of contact for all legal questions and management of legal, regulatory and quality subcontractors.
  • Advice and management on contracts.
  • Control of product conformity and batch release.
  • Deal with Market authorizations : Management and validation of market authorization files.
  • Review of promotional materials.
  • Management of complaints and vigilance reporting.
  • Main contact for the health authorities and notified bodies.
  • Depending on the profile:
    • Market access definition and implementation together with the marketing and sales people.

Professional Requirements:

  • With at least one year of experience in medical devices regulatory affairs and training in regulatory affairs , the medical devices field holds no more secrets for you (knowledge of software medical devices is clearly an asset).
  • You have already implemented the new European regulation on MD in the past.
  • You care about having a job that matters and provides help to others.
  • Your professional excellence, organization and hindsight allow you to handle complex projects and multiple questions on your own.
  • You are passionate about your work and enthusiastic about progressing every day, so you have no qualms about being involved in the marvellous and challenging endeavours of a start-up.
  • Advanced English and french.

What we offer ?

  • Salary depending on profile.
  • Private health insurance for you and if applicable, your family.
  • Flexible working hours, working from home whenever it suits you.
  • Participating in the growing success growth of our start-up and having the satisfaction at the end of each day that you have progressed and helped others.

How do we apply ?  julie-vandenbergue@optim-care.com