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Quality Specialist

2 weeks ago

Gävle, Gävleborg, Sweden EPM Scientific Full time

Quality & Regulatory Affairs Specialist - Medical Device Manufacturing (Sweden )

Join a
global leader in medical technology
on a key manufacturing project in Sweden We're seeking
Quality & Regulatory Affairs Specialists
to ensure
compliance, product integrity, and adherence to international standards
throughout the device lifecycle.


Location:
Sweden (Hybrid)


Duration:
12-month contract


Start:
ASAP

Your Role

  • Oversee
    quality and compliance activities
    in alignment with
    ISO 13485
    ,
    EU MDR
    , and global regulations.
  • Support
    regulatory submissions
    , technical documentation, and
    audit readiness
    .
  • Collaborate with cross-functional teams to maintain
    GMP standards
    and
    risk management processes
    .
  • Act as a key point of contact for
    Notified Body interactions
    and internal quality reviews.

Key Requirements

Proven experience in
quality assurance and regulatory affairs
within
medical device manufacturing
.

Strong knowledge of
ISO 13485
,
EU MDR
, and familiarity with
FDA 21 CFR Part 820
.

Understanding of
infection prevention technologies
,
sterile reprocessing
, and
operating room solutions
.

Skilled in
compliance oversight
,
technical documentation
, and
risk-based quality systems
.

Detail-oriented, proactive, and collaborative mindset.


Interested?
Send your CV and availability today - first batch of submissions goes out
today