- Establish and maintain overview and exchange on current and evolving regulatory requirements in Europe, with primary focus on medical devices.
- Provide expert regulatory input to strategic decision making, and ensure that regulatory strategies and regulatory operational activities are effectively executed to meet the business objectives and legal requirements, in close collaboration with Regulatory Operations and other internal stakeholders.
- Manage the maintenance activities potentially including Life Cycle Management strategy for medical devices in Europe, and in collaboration with the Regulatory Operations.
- Ensure regulatory compliance and maintenance of all product registrations and licenses throughout the whole life-cycle of the products under his/her responsibility.
- Ensure timely submission of high quality responses to queries raised by regulatory agencies and follow up on these requests.
- Provide support to the Regulatory Affairs Managers in the hubs in topics related to medical devices.
- Write comprehensible, clear Regulatory Assessments and documents for internal and external stakeholders (eg. Authorities and trade Associations).
- Ensure that regulatory submissions and other deliverables meet strict deadlines and fulfill European regulatory standards.
- Support in the development and implementation of regulatory standards that convey the best practices in the regulatory department.
- Establish strong relationships within the European organization, Regulatory Operations and Global Technology partners on a cross-functional basis including Marketing, Legal, Technical, Supply Chain, Regulatory and Product Safety, to ensure alignment and synchronization between Regulatory strategies and Business goals.
- Provide regulatory support on day-to-day regulatory issues, new initiatives and developments, including training to internal stakeholders and support to the Regulatory Affairs Managers in the hubs in topics related to the products and projects under his/her responsibility.
- Provide assistance to authority inspections in the matters under Regulatory responsibility.
- Represent CP's interest in selected European and Local Trade Associations and share information with internal stakeholders.
- Ensure the review and approval of artworks for products and territories under his/her responsibility.
- Provide input for budget preparation and reviews.
- Collaborate in regional and global regulatory projects and act as a project manager in the projects assigned to him/her.
- Contribute to an effective use of the network of regulatory consultants, including coordination with procurement and legal for contract negotiations and FCPA and Due Diligence processes.
- Relevant Master degree in Pharmacy, Biology, Chemistry or equivalent
- Minimum 3-5 years of Regulatory Affairs experience in an international environment, FMCG preferred, in the field of Medical Devices.
- Fluency in English is required, other european languages, is highly valuable
- Good analytical skills and technical/ scientific competence
- Strong organizational skills
- Attention to details and ability to appropriately assess the regulatory impact and formulate actionable strategy, including taking "the big picture" view on various options
- Effective communication, keeping people well informed of plans, goals and objectives, and sharing information openly
- Responds to day-to-day issues and problems with simple, timely and practical solutions.
-
Business Support Intern-Warsaw
Znalezione w: Talent PL Premium - 3 dni temu
Boston Scientific Błonie, PolskaPurpose and Passion · • Comprehensive Benefits · • Life-Work Integration · • Community · • Career Growth · At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, i ...
-
Specjalista / Specjalistka ds. wyrobów medycznych
Znalezione w: beBee S2 PL - 4 dni temu
pracuj Warszawa, Polska contract of employmentAbout Us:, We are a consulting firm established in 2023, focusing on medical devices and cosmetics. With roots in Korea and a network of 14 professional consultants, we've expanded our expertise to Poland, aiming to offer professional consulting services to European and global ma ...
-
Senior Cloud DevOps Engineer
Znalezione w: JustJoinIT PL C2 - 2 dni temu
Alcon Warszawa, Polska W pełnym wymiarze godzinAbout the Role: · Join our vibrant team and play a crucial role in shaping Alcon's Digital Cloud Products for ophthalmic medical devices. You'll design, manage, and improve cloud-based solutions, leading the way in automating pipelines, ensuring system resilience, and streamlini ...
-
Senior Security Engineer Vulnerability Detection
Znalezione w: Adzuna PL C2 - 5 dni temu
Google -, Warszawa, Polska W pełnym wymiarze godzinAbout the job · We are the Security and Privacy engineering team within Google's Devices and Services product area. Our mission is to embed and support robust security and privacy practices throughout the product lifecycle, ensuring the trustworthiness of all devices, apps, and s ...
-
Network Operation Center Engineer @
Znalezione w: Jobs Search PL C2 - 1 dzień temu
Ework Group Warsaw, Polska W pełnym wymiarze godzinHigher level of education At least 3 years of experience in the area of Network Operation as Engineer Hands-on experience with Cisco devices - routing and switching Knowledge of TCP/IP; knowledge of SDA/DNA Center will be a plus Hands-on experience with network monitoring tools a ...
-
Technical Lead Pixel Display Software
Znalezione w: Adzuna PL C2 - 3 dni temu
Google -, Warszawa, Polska W pełnym wymiarze godzinAbout the job · Pixel System Software works closely with Android Platform, Pixel Hardware, gChips, and external partner teams to bring the best of Android to users on Google's Pixel phones. Within Pixel System software, our display team is responsible for all things display for P ...
-
CEE Regulatory Innovation Manager
Znalezione w: Appcast US A2 ECP - 2 dni temu
Haleon Warsaw, Polska W pełnym wymiarze godzinHello. 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 ...
-
QA Engineer at Aura from Unity
Znalezione w: Adzuna PL C2 - 3 dni temu
On The Spot Development Prosta , Warszawa, Polska W pełnym wymiarze godzinUnity-Aura is the market standard for creating rich device experiences that engage and retain customers. It optimize every facet of the device experience, analyze customer engagement at every phase of the device lifecycle and do promotions in a most native way. · Aura was founded ...
-
Senior Data Analyst
Znalezione w: JustJoinIT PL C2 - 2 dni temu
PL18 Alcon Polska Sp. z o.o. Company Warszawa, Polska W pełnym wymiarze godzinAbout Alcon: · A career at Alcon is like no other. We are innovative. We are impactful. We are the largest eye care medical device company helping restore sight and allowing millions of people worldwide to see brilliantly. We have a long history of industry firsts and a diverse ...
-
Kernel Technical Lead Manager Pixel Core Platform
Znalezione w: Adzuna PL C2 - 5 dni temu
Google -, Warszawa, Polska W pełnym wymiarze godzinAbout the job · Google's software engineers develop the next-generation technologies that change how billions of users connect, explore, and interact with information and one another. Our products need to handle information at massive scale, and extend well beyond web search. We' ...
-
Senior Software Engineer Pixel Power
Znalezione w: Adzuna PL C2 - 1 dzień temu
Google Warszawa, PolskaAbout the jobGoogle's software engineers develop the next-generation technologies that change how billions of users connect, explore, and interact with information and one another. Our products need to handle information at massive scale, and extend well beyond web search. We're ...
-
On-site It Support Engineer
Znalezione w: Jobs Search PL C2 - 2 dni temu
Cognizant Warsaw, Polska W pełnym wymiarze godzinAbout-project : We are currently looking for On-site IT Support Technician willing to assist each line of the business from the technical perspective on the shift basis. · responsibilities : Serving as the first point of contact for customers seeking technical assistance in perso ...
-
Sales Representative
Znalezione w: Talent PL Premium - 6 dni temu
Nipro Europe Group Warsaw, PolskaAs a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading hea ...
-
Windows Support Engineer
Znalezione w: Adzuna PL C2 - 1 dzień temu
ITDS Warszawa, PolskaJoin us, and embrace the challenge of enhancing IT ecosystems · Warsaw-based opportunity with the possibility to work fully remotely · As a Windows Infrastructure Support Engineer, you will be working for our client, a leading global technology solutions provider, contributing to ...
-
Senior iOS Developer
Znalezione w: Adzuna PL C2 - 1 godzina temu
Integral Solutions Warszawa, Polska W pełnym wymiarze godzinFor our customer, an international company operating in the sports industry, we are looking for experienced people on the positions: · Senior iOS Developer · Workplace: Hybrid mode (at least 4 days in the Warsaw office) · Project Description: · The project entails creating a devi ...
-
Regulatory Affairs Specialist
Znalezione w: Talent PL Premium - 3 dni temu
Smith+Nephew Warsaw, Polska W pełnym wymiarze godzinLife Unlimited. · At Smith+Nephew we design and manufacture technology that takes the limits off living. · The Regulatory Affairs Specialist is responsible for representing and supporting the regulatory activities in NON EU-CEE Export Markets. · What will you be doing: · Provid ...
-
Technical Account Manager
Znalezione w: Adzuna PL C2 - 1 godzina temu
Perfect Gym Solutions Piaseczno, Polska W pełnym wymiarze godzinWe are a global SaaS company that offers a scalable open software platform to empower fitness and leisure businesses to thrive in today's dynamic market. Our innovative solutions are designed to facilitate their digital transformation and help them accomplish their goals while de ...
-
Network Specialist
Znalezione w: Jobs Search PL C2 - 1 dzień temu
Dsv Iss Warsaw, Polska W pełnym wymiarze godzinResponsibilities : Being part of Network Operations Center which actively manages over 30000 network devices (incl. · routers, switches, access points and more...) Deliver new network solutions: design, order hardware and implement network in our new offices and warehouses Partic ...
-
Technical Writer
Znalezione w: Talent PL Premium - 3 dni temu
Sonova Warsaw, PolskaPurpose of the job is to: develop thorough and compliant documentation for our hearing aids, chargers and accessories, which help in successful certification of those products in order to be approved for sale. Support the document update process for successive generations of devi ...
-
Senior Software Developer Security Privacy Pixel
Znalezione w: Adzuna PL C2 - 5 dni temu
Google -, Warszawa, Polska W pełnym wymiarze godzinAbout the job · Google's software engineers develop the next-generation technologies that change how billions of users connect, explore, and interact with information and one another. Our products need to handle information at massive scale, and extend well beyond web search. We' ...
Regulatory Affairs Specialist Medical Devices - Błonie, Polska - Colgate-Palmolive Company
Opis
No Relocation Assistance Offered
# Warsaw, Mazovia, Poland
Who We Are
Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, meridol, Protex, Sanex, , Speed Stick, Ajax, as well as Hill's Pet Nutrition.
We are looking for a Regulatory Affairs Specialist / Manager who will join our Warsaw office at Taśmowa Street. We work in a hybrid model - 3 days per week from home.
This regulatory position has European responsibilities on Medical Devices for Europe.
Direct Reports: None
Travel: <10%
Responsibilities:
Competencies Required:
If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team
Our Commitment to Sustainability
With the Colgate brand in more homes than any other, we are presented with great opportunities and new challenges as we work to integrate sustainability into all aspects of our business and create positive social impact. We are determined to position ourselves for further growth as we act on our 2025 Sustainability & Social Impact Strategy.
Our Commitment to Diversity, Equity & Inclusion
Achieving our purpose starts with our people — ensuring our workforce represents the people and communities we serve —and creating an environment where our people feel they belong; where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please contact with the subject "Accommodation Request" should you require accommodation.
#LI-Hybrid