Senior Manager (m/f/d) Regulatory Intelligence

☞ pates AG

View: 139

Update day: 07-10-2024

Location: Hamburg

Category: Sales Pharmaceutical / Chemical / Biotech

Industry:

Job type: Festanstellung

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Job content

4516
Medizintechnik
Festanstellung
15.04.23
Vor Ort
Hamburg

Kurzbeschreibung:
Medizintechnik

Festanstellung

Regulatory Affairs

Our client is a company in the field of medical technology, which develops and manufacturs center for rigid endoscopy, bipolar high-frequency surgery and reprocessin with more than 30,000 employees worldwide in nearly 40 countries.
Ansprechpartner
Elena Kuhn
kuhn@pates-experts.com
+49 89 1241 39 3914

Ihre Aufgaben

Perform regular monitoring laws and regulations with a focus on environmental-related regulation

Identify potential regulatory intelligence which may impact Olympus’ product portfolio

Develop and implement regulatory required processes

Aggregate identified regulatory intelligence and perform quality checks to confirm that information is accurate

Perform impact assessments on intelligence provided before sharing with other stakeholders (internal and external to Regulatory Affairs) to ensure intelligence is relevant and it is clear how this will impact Olympus’ portfolio and operations

Monitor the internal implementation status of changes required by new regulatory requirements based on regulatory intelligence

Partner with global RA functions to ensure new regulatory requirements are collected and analyzed

Drive quality mindset to reinforce the corporate brand and become a trusted, collaborative and preferred business partner across Olympus

Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International)

Ihr Profil

Scientific degree in Chemistry advantageous

Long-standing experience in regulatory affairs with specific experience in environmental regulations

Experience in standardization work and interpretation of technical standards in the product portfolio of Olympus appreciated

Regulatory project management support experience

Experience supporting significant parts of the end-to-end product lifecycle management activities

Experience authoring and or managing a range of global regulatory submissions (e.g., 510(k), CE Mark, etc.)

Experience managing and operating QMS processes and systems

Experience in working globally with understanding of global process flows and teaming

Strong IT skills, experience utilizing a relevant regulatory system (ideally RIM/PLM), QMS systems and basic Office

Good management of working relationships within Regulatory Affairs and with other internal departments (R&D, Manufacturing, Supply Chain, Quality, etc.)

Strong written and verbal communication skills in an international environment
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Deadline: 21-11-2024

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