Regulatory Strategy & Compliance: Apply scientific, regulatory, and business knowledge to ensure compliance for medicinal products and medical devices throughout their life cycle.
Regulatory Submissions & Registrations: Prepare, assemble, and submit regulatory applications to Competent Authorities and Notified Bodies to achieve and maintain product registrations within EMEA.
Change Control & Lifecycle Management: Participate in site change control processes and ensure regulatory impact assessments are received and properly filed from all global regions.
Collaboration & Regional Support: Work closely with the Director, Regulatory Affairs EMEA, to support regional regulatory projects and initiatives.
Manufacturing, Audits & Distribution: Ensure regulatory distribution release activities for medical device products and support inspections and audits by Competent Authorities and Notified Bodies at manufacturing sites.

University degree in Life Sciences, Pharmacy, Medical device Engineering, or another relevant scientific discipline
Strong regulatory knowledge especially in EMEA medical / medical Device products regulations and ideally experience in CE marking of medical devices (class IIa and above; for 4-6 years); experience with CE marking of ophthalmic medical devices is of advantage.
Managerial responsibility (at least 2 years) – including supervisor responsibility
Hands‑on experience with regulatory submissions to Competent Authorities and/or Notified Bodies
Solid understanding of European regulatory frameworks, including MDR
Experience supporting product lifecycle management and change control processes
Fluent in English both written and verbal (Swedish is advantage).

an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
vacation days
parental leave for a minimum of 12 weeks
bereavement leave
caregiver leave
volunteer leave
well-being reimbursement
programs for financial, physical and mental health
service anniversary and recognition awards
subject to the terms of their respective plans, employees
and in some location’s eligible dependents
can participate in several insurance plans.

Regulatory Affairs Manager, EMEA

Key skills