- 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.
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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
