Regulatory Affairs Specialist with German

Poland·Warsawmid

Legal & ComplianceRegulatory Affairs Specialist

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Quick Summary

Key Responsibilities

Management of medical devices (Vision Care: contact lenses and care solutions; Ophthalmic Surgery: visualization equipment, irrigation solutions, viscoelastics, microinvasive surgery, etc.

Requirements Summary

Bachelor Degree (best in Pharmacy) and 5+ years of relevant experience. Fluent English and German - min. B2 Good knowledge of regulatory requirements (AMG, HWG,

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Legal & ComplianceRegulatory Affairs Specialist

The responsibilities include scientific and administrative activities aimed at ensuring the conditions for the proper marketing of our medical devices and medicinal products. The objective is to ensure that products on the market comply with current pharmaceutical and legal regulations (AMG, HWG, and MPG) and standards, and that corporate policies are adhered to. The role requires independence, initiative, and very good knowledge of pharmaceutical and medical device law.

Management of medical devices (Vision Care: contact lenses and care solutions; Ophthalmic Surgery: visualization equipment, irrigation solutions, viscoelastics, microinvasive surgery, etc.)

Approval and coordination of the translation process for informational texts (“labeling”), including complex device documentation and packaging material approvals.

Coordination with the Großostheim affiliate for all product-related activities.

Support and lifecycle management of our medicinal products, in particular:

Preparation and submission of variations, marketing authorization renewals, and PSURs

Review of chemical-pharmaceutical topics and documentation, as well as

Handling the resulting variation submissions

Revision of packaging texts, including patient information leaflets and summaries of product characteristics

In the case of product changes or discontinuations, cost-conscious coordination of packaging material stock depletion and product inventory sell-off timelines

Coordination of the CCSI safety labeling update process: tracking and ensuring the implementation of safety-relevant information in the labeling texts of all products marketed in Germany. Monitoring compliance with KPIs based on monthly reports from iMedidata

Requirements

~1 min read

Bachelor Degree (best in Pharmacy) and 5+ years of relevant experience.
Fluent English and German - min. B2
Good knowledge of regulatory requirements (AMG, HWG, MPG)
Solid pharmaceutical knowledge (marketing authorization dossier)
Very good computer skills (MS Office)

Opportunity to expand knowledge and experience in the field of regulatory affairs.
Friendly working environment and a diverse and highly motivated team
Very best working environment for our employees – Alcon Polska has been recognized as a Top Employer for the two years in a row
Truly international environment and daily interactions with colleagues and stakeholders from all over the world
Attractive benefits package (private medical care, group insurance, lunch card, transportation allowance, pension plan, Multisport/cultural card, Alcon products for you and your significant other)
Moderrn office with a lot of facilities inside located at NewCity building, 15 Marynarska Street, Warsaw

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