Bogna Antonczyk Email & Phone Number

Warsaw, Pl

Polska Warszawa

Warszawa, Woj. Mazowieckie, Polska

Complaints management, regulatory submissions to EMEA countries, different project management, supporting distributors in MEA

Warszawa, Poland

Strategy setting for the region. Regulatory submissions oversight of all Boston Scientific products in 30 European and Asian countries including Clinical Trials and SAE reporting. Managing of 12 employees responsible for registration in specific countries including Israel ,Russia, Kazakhstan Serbia and Uzbekistan. Responsible for Vigilance processes implementation across the region ,Change Management processes , registration updates, local strategies implementation and regional budget. Clinical… Show more Strategy setting for the region. Regulatory submissions oversight of all Boston Scientific products in 30 European and Asian countries including Clinical Trials and SAE reporting. Managing of 12 employees responsible for registration in specific countries including Israel ,Russia, Kazakhstan Serbia and Uzbekistan. Responsible for Vigilance processes implementation across the region ,Change Management processes , registration updates, local strategies implementation and regional budget. Clinical Investigation submission oversigh. Support Endoscopy division as RA lead for entire EMEA. Show less

Warsaw, Mazowieckie, Poland

Responsibilities as above , just the title and region name has been changed.

Basel Area, Switzerland

As Global HQ regulatory employee my duties are: Support all 65 different countries in EMEA , Asia and South America regions in terms of (product approvals )registration requirements and submissions to CA or Health Authorities, as well as tender documents providing. Releasing /listing specific products to appropriate countries. Artworks / IFU/ Labels approval globally as legal manufacturer. Master labels/ IFU approval. Technical and design changes approval by product via different technical… Show more As Global HQ regulatory employee my duties are: Support all 65 different countries in EMEA , Asia and South America regions in terms of (product approvals )registration requirements and submissions to CA or Health Authorities, as well as tender documents providing. Releasing /listing specific products to appropriate countries. Artworks / IFU/ Labels approval globally as legal manufacturer. Master labels/ IFU approval. Technical and design changes approval by product via different technical softwares. Agree regulatory strategy for all 65 countries with commercial and regulatory heads.PCR ( Product Change Request) proceeding and approvals. Cooperation with Swissmedic and other CA in terms of FSC and other documents obtaining required for registration in many countries worldwide. Recalls / FA / Complaints management Show less

Manage pre-and post-market regulatory requirements for all 24 countries in the region. Regulatory submissions to 24 different CAs/MoH(s) across my region. CLINICAL TRIALS approvals obtaining at CA(s) and SAE reporting. Managing AE reporting , Vigilance, Reporting to CAs , FA/ FSCA driving. Developed improved processes for regulatory compliance. Represented ABT in all interactions with registration authorities e.g. President of CA & Quality control authorities

Warsaw, Masovian District, Poland

Strategy settings for the region with commercial head.Regulatory Submissions to all countries covered by NCER region ( All Nordics, Central Europe & Russia). Clinical Trials registration at CAs ( EU + CIS )Vigilance , SAE reporting , FSCA conducting , clinical trials registration and AE reporting , tenders supporting from regulatory stand point ,regulatory intelligence and oversigh. Clinical Investigation approvals obtaining from CAs.

EMEA regulatory affairs experience emphasizes a strong focus on Europe. Thorough understanding EU and other global regulations with RA focus on EU in medical devices business. Quality certified auditor ( ISO9001). Thorough knowledge of Clinial Trials registration at Governmental Agencies. Solid relationships with the intent to facilitate the negotiation of registration paths. Recognized change agent and problem solver with the tenacity to produce win-win outcomes.

Warszawa, Woj. Mazowieckie, Polska

All regulatory activities related to IVD products ; notification to CA, FSCA conducting , Adverse Events reporting to HQ and to CA; tenders supporting ; quality system supervision , implementation and maintenance

Polska

Responsible for all activities at Customer Service Center :offers preparation , signing contracts ,documentation control,contracts negotiations with customers, manage and control of 42 people working at the CS Center. Change Management ( reduced to 15 employees ).Assure legal aspects of contract signing. Advise and make decision about equipment , safety and architectural arrengements.

Warszawa, Woj. Mazowieckie, Polska

Medical Devices registration at CA. Vigilance system implementation and maintenance. Quality ISO9001 management system implementation from scratch to BSI Certification. Cooperation with Eucomed , Polmed and American Chamber of Commerce. Regulations in Adverstising and Promo materials implementation.

Warszawa, Woj. Mazowieckie, Polska

SYNTHES -STRATEC MEDICAL division. Responsible for : ordering products from Switzerland, prices negotiations with Swiss Plant, contracts negotiation with hospitals, tenders decumentation arrangement, customs clearance support, all customer service and logistic services. Also responsible for AO/ASIF courses organization in Poland for 64 orthopaedic surgeons in cooperation with Swiss HQ and hospitals.