Possible locations
  • Polska
  • Remote work
Technologies & tools
  • ISO 13485
  • ISO 14971

We are looking for a Regulatory Affairs Specialist for medical devices who will be responsible for planning, leading, and executing regulatory activities in R&D projects for international clients from the Medical Devices and Products sector. You will work closely with teams across sites under design control and ensure that the client adheres to internal QMS and our Risk lifecycle process.

Your role

  • Ensuring communication with various stakeholders
  • Cooperating with R&D cross-functional teams
  • Writing and maintaining documentation
  • Working closely with teams from areas of area mechanics/electronics/software/usability/biocompatibility
  • Ensuring compliance with medical regulations and standards

Your skills
  • At least 2 years of experience working as a Regulatory Affairs Specialist
  • Knowledge and understanding of medical device development and design control
  • Proven experience with ISO 14971 and ISO 13485

Job no. 241015-BRCKU

Why Sii

Great Place to Work since 2015

it’s thanks to feedback from our workers that we get this special title and constantly implement new ideas

Fascinating projects

prestigious brands from around the world, long-term contracts and preferred partner status for many clients

Project suited to you

Do you want to change your career path? Is your project coming to an end? We’ll find you a new one! We have an app for this – Job Changer

We share the profit with Workers

Last year we allocated PLN 2,1BN to this benefit

PLN 500 000 per year for your ideas

with this amount, we support the passions and voluntary actions of our workers

7 500 experts and many development opportunities

Tech Communities, workshops, a training platform, and a technology blog – you choose

Employment stability

revenue of EUR 300 M, no debts, since 2006 on the market

Great, comfortable offices

perfect place to work, integrate, have fun together, and celebrate successes

Open-minded and available management team

quick decision-making, we’re all on a first-name basis

True values

these are not empty words – we’re guided by them every day

Fantastic atmosphere

created by all Sii Power People

Attractive benefits package

private healthcare, benefits cafeteria platform, car discounts and more

Show more Show less

Join us

Allowed extensions: DOC, DOCX, PDF (max 5MB)

Your message was sent successfully.

Thank you!

Find out more about Sii

Sorry, something went wrong and your message couldn’t be delivered.

Please refresh the page and try again.

File upload error

No file was uploaded

Incorrect file size (max 5MB)

Invalid file format

Empty file

Processing...

Do you have a friend looking for a new role?

Bring them to Sii and receive a bonus

Introduce your friend
We hire them
You get up to 15 000 SEK

Recommended person data

Allowed extensions: DOC, DOCX, PDF (max 5MB)

Your data

Terms and conditions
Introduce your friend
We hire them
You get up to 15 000 SEK

Your message was sent successfully.

Thank you!

Find out more about Sii

Sorry, something went wrong and your message couldn’t be delivered.

Please refresh the page and try again.

File upload error

No file was uploaded

Incorrect file size (max 5MB)

Invalid file format

Empty file

Processing...

Apply now Recommend a Friend

SUBMIT

This content is available only in English version.

Are you sure you want to leave this page?

Detta innehåll är endast tillgängligt på engelska.

Är du säker på att du vill lämna sidan?