Regulatory Affairs Coordinator

2 miesięcy temu

Warsaw, Polska Abbott Pełny etat

The Opportunity

:

For our Rapid Diagnostics Division we are looking for an experienced professional to join our international, regulatory team as a Regulatory Affairs Coordinator . This will be a full-time, office-based role working out from our Warsaw (Mokotow) location.

The successful candidate will start on a 12-months, fixed-term contract with an external agency (umowa o pracę na czas określony).

What You'll do:

This is a role with two components where you will be responsible for the project management of IVDR transition in the EMEA region as well as all regulatory related activities related to product registration and life cycle management of the Rapid Diagnostic Portfolio in the Western Europe region.

IVDR implementation:

Work closely with Global Project Manager and country Regulatory teams to gather status updates for EMEA Set up and lead a monthly EMEA IVDR cross functional meeting to share progress of the IVDR project in the region  Track metrics in monthly Regulatory Review meeting

Western Europe:

Be the primary point of contact for Abbott Affiliates and distributors in the region for Regulatory related activities  Work closely with the manufacturing sites to gather the necessary documents needed for local notification when required. Track Regulatory submissions and approvals in Abbott database in a timely manner and with high quality data accuracy  Maintain regulatory and language requirements for the region Monitor applications under regulatory review. Communicate application progress to internal stakeholders.  Provide regulatory input to product lifecycle planning and strategies. Ensure compliance with product post marketing approval requirements  Review and approve advertising and promotional items to ensure regulatory compliance. Ensure external communications meet regulations. Monitor impact of changing regulations and update internal stakeholders.  Represent Abbott in industry association meeting  Represent Regulatory in cross functional meetings  Other duties as assigned, according to the changing needs of the business.

Required qualifications and background:

Minimum of a Bachelor’s Degree (BA/BS) from an accredited University. Minimum of 5 years of experience in a Biotech / Pharma / Medical Device/ IVD/ Regulated Industry. Experience in project management. Experience in data management and Power BI would be a plus. Proficient in English. French, Spanish or Italian would be a plus. Demonstrated success in the Pharma or Medical Device Industry. Good knowledge of EU regulations. Excellent communication and relationship management skills. Ability to adapt quickly and effectively to shifting priorities. Very strong attention to detail. Strong sense of ownership. Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment. Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.

  • Regulatory Affairs Specialist

    2 miesięcy temu

    Warsaw, Polska Novo Nordisk Pełny etat

    The position As a Regulatory Affairs Specialist, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). You will ensure Regulatory Affairs compliance according to local legislation and Standard Operation Procedures (SOPs). Your main responsibilities will...

  • Regulatory Affairs Support

    2 miesięcy temu

    Warsaw, Polska Randstad Polska Pełny etat

    Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team. what we offeremployment contract for 12 months with the possibility of extensionhybrid work (2 days a week remote work)benefits package: medical care, multisport card, life insurancework in an...

  • Junior Regulatory Affairs Specialist

    1 miesiąc temu

    Warsaw, Polska Randstad Polska Pełny etat

    Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team. what we offeremployment contract for 12 months with the possibility of extensionhybrid work (2 days a week remote work)benefits package: medical care, multisport card, life insurancework in an...

  • Regulatory Affairs Analyst EU

    3 tygodni temu

    Warsaw, Polska Danaher Corporation Pełny etat

    Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates...

  • Senior Regulatory Affairs Specialist

    3 tygodni temu

    Warsaw, Polska Allegro sp. z o.o. Pełny etat

    Job DescriptionAllegro Group is seeking two Senior Regulatory Affairs Specialists to join our Regulatory Affairs team focused on Poland and the CEE region. In this role, you will be instrumental in shaping critical legislation, including postal, customs, logistics, and tax laws, as well as the AI and tech-related legislation. You will monitor legislative...

  • Regulatory Affairs Specialist

    2 miesięcy temu

    Warsaw, Polska Randstad Polska Pełny etat

    Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team. what we offeremployment contract for 12 months with the possibility of extensionhybrid work (2 days a week remote work)benefits package: medical care, multisport card, life insurancework in an...

  • Regulatory Affairs Specialist

    3 miesięcy temu

    Warsaw, Polska RICG Poland Sp. z o.o. Pełny etat

    Are you a dedicated Regulatory Affairs Specialist looking to advance your career in a dynamic pharmaceutical company? We are seeking a highly motivated individual with a background in Polish and European regulatory law to join our team.Key Responsibilities:Ensure compliance with Polish and European regulations for pharmaceutical productsLiaise with internal...

  • Medical Device Regulatory Affairs Lead

    3 tygodni temu

    Warsaw, Polska myGwork Pełny etat

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. We are looking for a Regulatory Affairs Consultant - Medical Device Regulatory Lead for Alliance Combination Products will oversee key regulatory activities and report to...

  • AGS Regulatory Affairs Analyst

    2 miesięcy temu

    Warsaw, Polska PL18 Alcon Polska Sp. z o.o. Company Pełny etat

    At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...

  • Medical Device Regulatory Affairs Specialist

    3 tygodni temu

    Warsaw, Polska myGwork Pełny etat

    Job Title: Medical Device Regulatory Affairs LeadThis role is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. We are looking for a highly skilled Regulatory Affairs Consultant to lead our medical device regulatory efforts.Key Responsibilities:Serve as Device Regulatory Lead on...

  • Medical Device Regulatory Affairs Lead

    1 miesiąc temu

    Warsaw, Polska Pharmiweb Pełny etat

    We are looking for a Regulatory Affairs Consultant - Medical Device Regulatory Lead for Alliance Combination Products will oversee key regulatory activities and report to the Global Device Regulatory Head for Alliance Combination Products, who in turn reports to the Head of GRA Device. In this role you will provide strategic and tactical support on...

  • Associate Director, Regulatory Affairs

    2 miesięcy temu

    Warsaw, Polska Innovaderm Research Pełny etat

    The Associate Director, Regulatory Affairs is responsible for managing and overseeing the services provided by the Regulatory Affairs group in the assigned regions, and to ensure they are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction....

  • Intern, Regulatory Affairs

    5 miesięcy temu

    Warsaw, Polska SC Johnson Professional Pełny etat

    Intern, Regulatory Affairs Assistant to Regulatory and Registration Manager Location: Warsaw Overview The purpose of an internship is to provide real-world experience that enables the intern to put everything he/she learned into action. An internship can help the candidate gain skills that can be applied to future jobs. As an Intern,...

  • Regulatory Affairs Manager CEE

    5 miesięcy temu

    Warsaw, Polska Galderma Pełny etat

    Description Key Responsibilities Lead regulatory strategy development and execution for CIS and non-EU CEE countries, ensuring timely and high-quality submissions. Manage the entire registration process, including new product approvals, manufacturing and import permits, and product amendments. Support distributors in interactions and...

  • Regulatory Affairs Expert

    4 tygodni temu

    Warsaw, Polska Allegro sp. z o.o. Pełny etat

    Job DescriptionJoin Allegro in our mission to ensure product safety, enforce anti-counterfeit policies, and promote sustainability! We are seeking a dedicated professional to monitor, analyze, and engage with EU and Polish legislation related to product safety, sustainability, and consumer empowerment for the green transition. You will play a crucial role in...

  • Regulatory Affairs Expert

    3 tygodni temu

    Warsaw, Polska Allegro sp. z o.o. Pełny etat

    Job DescriptionJoin Allegro in our mission to ensure product safety, enforce anti-counterfeit policies, and promote sustainability! We are seeking a dedicated professional to monitor, analyze, and engage with EU and Polish legislation related to product safety, sustainability, and consumer empowerment for the green transition. You will play a crucial role in...

  • Regulatory Affairs Lead, CEE Export Markets

    5 miesięcy temu

    Warsaw, Polska Haleon Pełny etat

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of...

  • Regulatory Projects Coordinator – M/F/DPermanent contractWarsaw, Poland

    4 miesięcy temu

    Warsaw, Polska Société Générale Assurances Pełny etat

    Regulatory Projects Coordinator – M/F/D Permanent contract|Warsaw|Innovation / Project / Organization Regulatory Projects Coordinator – M/F/D Warsaw, Poland Permanent contract Innovation / Project / Organization Responsibilities Société Générale Global Solution Center Poland is a new, growing area of the SG Warsaw Branch,...

  • Quality & Regulatory Affairs Associate

    1 miesiąc temu

    Warsaw, Polska Zimmer Biomet Pełny etat

    JOB DESCRIPTION At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.  As a Zimmer Biomet team member, you will share in our commitment to providing...

  • Regulatory Affairs Specialist

    2 tygodni temu

    Warsaw, Polska Boston Scientific Pełny etat

    Additional Locations:  N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...