Senior Regulatory Affairs Specialist/Manager

2 tygodni temu

Warszawa, Mazovia, Polska HAYS POLAND Sp. z o.o. Pełny etat
Senior Regulatory Affairs Specialist/Manager Warsaw, Masovian Voivodeship

Job Responsibilities:

1. Stay up-to-date with evolving regulatory requirements in Europe, particularly for medical devices.

2. Offer expert regulatory advice for strategic decision-making, ensuring effective execution of regulatory strategies.

3. Manage maintenance activities and lifecycle strategies for medical devices in Europe.

4. Ensure regulatory compliance for all product registrations and licences throughout their lifecycle.

5. Submit high-quality responses to regulatory queries promptly.

6. Support Regulatory Affairs Managers on medical device-related topics.

7. Produce clear Regulatory Assessments and documents for both internal and external stakeholders.

8. Meet strict deadlines and European regulatory standards for submissions and deliverables.

9. Contribute to developing and implementing regulatory standards aligned with best practices.

10. Build strong cross-functional relationships within the organisation and with external partners.

11. Provide day-to-day regulatory support, training, and assistance during authority inspections.

12. Represent company interests in European and Local Trade Associations.

13. Review and approve artworks for products and territories.

14. Provide input for budget preparation and participate in reviews.

15. Collaborate on regional and global regulatory projects, acting as a project manager when assigned.

16. Coordinate with procurement and legal for regulatory consultant contracts and due diligence processes.

1. Master's degree in Pharmacy, Biology, Chemistry, or equivalent.

2. 3–5 years of Regulatory Affairs experience in an international environment, preferably FMCG, focusing on Medical Devices.

3. Fluency in English; knowledge of other European languages is advantageous.

4. Strong analytical skills and technical/scientific competence.

5. Excellent organizational skills and attention to detail.

6. Ability to assess regulatory impact and formulate actionable strategies.

7. Effective communication skills, keeping stakeholders well-informed.

8. Ability to provide practical solutions to day-to-day issues and problems.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

Hays Poland sp. z o. o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.

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