Regulatory Affairs Lead

7 dni temu


Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

Solventum is a leader in the healthcare industry, dedicated to creating innovative solutions that improve lives. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements across the globe.

Job Description

In this position, you will be responsible for leading cross-functional teams and overseeing product line submissions and registrations worldwide. You will work closely with the international regulatory affairs group to ensure products meet global regulatory standards.

The ideal candidate will possess a strong understanding of regulatory affairs and have experience authoring submissions and technical documentation for US, Canada, EU, and supporting EMEA, APAC, and LATAM regions.

You will also have the opportunity to support labeling and registration changes due to company spin-offs.

Key Responsibilities:

  • Conducting global regulatory change assessments and coordinating associated activities for assigned products.
  • Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills.
  • Providing regulatory review of technical reports and documents.
  • Providing contributions for development and implementation of regulatory processes.
  • Documenting and managing metrics.
  • Leading regulatory filings as needed for continuity projects (directly for EU/USA, and supporting ROW).
  • Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight.
Requirements

To succeed in this role, you will need:

  • Bachelor's Degree or higher from an accredited university in a scientific discipline such as Biology, Chemistry, Biomedical Engineering, or Physics.
  • 7-10 years in regulatory affairs in the medical device industry.
  • Direct experience authoring submissions/technical documentation for US, Canada, EU, and supporting EMEA, APAC, and LATAM regions.
  • Direct experience authoring regulatory strategies and regulatory change assessments.
  • Expert technical writing and verbal skills in the English language.


  • Wrocław, Województwo dolnośląskie, Polska TN Poland Pełny etat

    At TN Poland, we are seeking a highly skilled Regulatory Affairs Professional to join our team. In this role, you will be responsible for executing the regulatory affairs strategy for our snacks business, ensuring compliance with all applicable regulations.Key Responsibilities:Develop and implement regulatory affairs strategies to ensure compliance with...


  • Wrocław, Województwo dolnośląskie, Polska 却数慮 Pełny etat

    Job DescriptionPosition can be based in France, Poland or UKThe Regulatory Affairs Officer ensures appropriate registration and legal compliance of a portfolio as a key link between Stepan, its products, and regulatory authorities.Your main responsibilities will be:Lead regulatory affairs activities to support Stepan in developing, manufacturing, and putting...


  • Wrocław, Województwo dolnośląskie, Polska Stepan Company Pełny etat

    Job DescriptionPosition can be based in France, Poland or UKThe Regulatory Affairs Officer ensures appropriate registration and legal compliance of a portfolio as a key link between Stepan, its products, and regulatory authorities.Your main responsibilities will be:Lead regulatory affairs activities to support Stepan in developing, manufacturing, and putting...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    At Solventum, we empower innovative healthcare solutions that transform lives. As a new company born from 3M Healthcare's legacy, we continue to pioneer breakthrough technologies at the intersection of health, materials, and data science.The Senior Regulatory Affairs Specialist will be responsible for leading cross-functional teams and owning product line...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    We are committed to delivering innovative healthcare solutions that improve patient outcomes and enhance the overall quality of life. As a new company, we leverage our rich legacy of creating breakthrough solutions to tackle the toughest challenges in healthcare.The Senior Regulatory Affairs Specialist will be responsible for driving regulatory excellence...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...


  • Wrocław, Województwo dolnośląskie, Polska TN Poland Pełny etat

    Job DescriptionThe Advanced Regulatory Affairs Associate EMEA role at TN Poland is an exciting opportunity to join our team as a senior regulatory compliance specialist.This position involves ensuring the compliance of 3M products' label information according to country-specific and European legislation.You will work closely with internal and external...


  • Wrocław, Województwo dolnośląskie, Polska TN Poland Pełny etat

    Social network you want to login/join with:Are You Ready to Make It Happen at Mondelēz International?Join our Mission to Lead the Future of Snacking. Make It With Pride.You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge. You ensure our policies,...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    Solventum is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and making strategic decisions that drive business growth.About the RoleThis is a leadership position that requires exceptional communication and problem-solving skills. The...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. As a Senior Regulatory Affairs Specialist, you will have the opportunity to make a significant impact on our organization.About SolventumWe are a new company with a long legacy of creating breakthrough solutions for our customers' toughest...


  • Wrocław, Województwo dolnośląskie, Polska TN Poland Pełny etat

    Advanced Regulatory Affairs Associate EMEA (m/f/x), WrocławClient:3MLocation:WrocławJob Category:OtherEU work permit required:YesJob Reference:e0d8af300179Job Views:3Posted:15.03.2025Expiry Date:29.04.2025Job Description:Advanced Regulatory Affairs Associate EMEA (m/f/x)The Impact You'll Make in this RoleAs an Advanced Regulatory Affairs Associate EMEA,...


  • Wrocław, Województwo dolnośląskie, Polska 却数慮 Pełny etat

    Key QualificationsTo succeed in this role, you will need:A minimum of 5 years of experience in regulatory affairs of industrial chemicals, crop protection, or biocides.Demonstrated project management skills.Fluent English language skills, both written and spoken.You will also have the opportunity to develop your skills further with our comprehensive training...


  • Wrocław, Województwo dolnośląskie, Polska Solventum Pełny etat

    Solventum is a dynamic and fast-paced company that values innovation and excellence. As a Senior Regulatory Affairs Specialist, you will have the opportunity to work with a talented team of professionals who share your passion for improving lives through better, smarter, safer healthcare.About the RoleThis is a challenging and rewarding position that...


  • Wrocław, Województwo dolnośląskie, Polska TN Poland Pełny etat

    Regulatory ExpertiseAs a Compliance Manager, you will be responsible for staying updated on AML (Anti-Money Laundering) and KYC (Know Your Customer) regulations across the EU and local markets.You will need to have excellent communication skills, speak and write English fluently, and possess deep knowledge of AML/KYC regulations.Responsibilities:Represent...


  • Wrocław, Województwo dolnośląskie, Polska 却数慮 Pełny etat

    Job DescriptionThe Regulatory Affairs Officer ensures appropriate registration and legal compliance of a portfolio as a key link between Stepan, its products, and regulatory authorities.Main Responsibilities:Lead regulatory affairs activities to support Stepan in developing, manufacturing, and putting on the market chemicals according to ad hoc chemical...


  • Wrocław, Województwo dolnośląskie, Polska Tbwa ChiatDay Inc Pełny etat

    Overview:Vonage is committed to driving transformation by providing innovative, customer-centric solutions that enable organizations to engage, interact, and deliver personalized service at scale.We bridge technology and business needs to deliver innovative products and services that redefine communication. Our team envisions the future, orchestrating...


  • Wrocław, Województwo dolnośląskie, Polska TN Poland Pełny etat

    Key ResponsibilitiesThe Senior Regulatory Compliance Specialist role at TN Poland involves ensuring the compliance of 3M products' label information according to country-specific and European legislation.You will work closely with internal and external customers to gather needs for label content development and monitor emerging regulations and trends in...