Bogumiła Helena Antończyk


Msc Eng

Personal Profile

Mila was a regulatory advisor on regulatory issues relating to the use and export of human tissues for scientific research by one corporate.

2016 – 2022 Mila was a Senior manager of Regulatory Affairs in EMEA at Boston Scientific where she was accountable for many different countries in EU, Eastern Europe, and Central Asia. Mila supported Clinical Trials submissions to Competent Authorities in EU but also, she paved the paths to understand Russian, Kazakh, and other CIS regulations related to Clinical Trials conducting and Patient Safety.

In 2015 Mila supported Bayer AG in Basel HQ as Regulatory Affairs Manager EU & EMEA at Bayer Healthcare AG (Diabetes Care)

2007– 2015 Regulatory Compliance & QA Manager SEE, CIS, Israel & RSA at ABBOTT Laboratories Poland, and ABBOTT VASCULAR where apart from other responsibilities she was cooperating with many Competent Authorities in Nordic countries, Eastern Europe, Israel, and South Africa to register clinical trials as well as to supervise patients’ safety (Severe Adverse Events Reporting)

2000 – 2004 Regulatory Affairs Advisor at STRYKER Poland where Mila was responsible for products approvals as well as she has created entire Quality Management System from scratch which was ISO9001 certification awarded by BSI (British Standard Institution).

1996 – 2000 Customer Service, Scientific Events Tender Specialist at MEDIM that was exclusive representative of SYNTHES – Stratec MEDICAL (Switzerland)at that time. Mila (among other responsibilities) supported International Foundation AO/ASIF with its site in Davos in organization of AO courses in Poland and Davos where orthopedic surgeons were trained by KOLs from US, Canada, Europe and other countries.


Regulatory Affairs & Quality Assurance Consultant for medical devices industry

Areas of expertise

  • MDD 93/42/EEC and 98/79/EEC regulation
  • MDR 2017/745 new EU regulation
  • Clinical Investigations approvals including Ethical Committees
  • SAE (Severe Adverse Events) reporting
  • QMS (Quality Management System) in medical devices system ISO13485
  • Post Market Surveillance
  • Patient Safety and Bio-Ethics passionate
  • Strategic solutions
  • Ethics and Compliance in MD business