Opublikowano: 2 grudnia 2019 o 15:48
Product Compliance & Regulatory Affairs Manager - Europe - IVD
Gliwice, śląskie, Polska
(Umowa o pracę)
Person on this position will be responsible for all activities regarding to Regulatory Affairs comes from medical devices production and distribution
For our client, leading global provider of integrated, tailored solutions for the life since and advanced technology we looking for Product Compliance & Regulatory Affairs Manager for Europe region. This recruitment is result of continued growth of company regarding to implementing new products and conquering new markets.
- Responsible for management of medical device design changes and (IVD) medical device technical documentation
- Keeps informed of regulatory regulations & changes.
- In cooperation with other stakeholders, implements the necessary changes to maintain company compliance, including SOPs & instructions, and registrations when required.
- Secure compliant products are placed on the market.
- Collaborate and support Local QA / Regulatory and Gliwice Plant for customer-facing activities.
- Local Regulatory Affairs is the local contact with authorities (participating on inspections, declarations & reporting, licenses requests)
- Local Legal requirements and legislation follow-up and update of Central team
- Provide inputs for suppliers product range introduction if local legislation to consider
- Ensure that local organisation is compliant with the Legal requirements
- Provides Regulatory support to the local Business and Operations Teams
- Science education or equivalent in Medical
- Knowledge of requirements on (IVD) medical device technical documentation (MDF per ISO 13485 or DHF & DMR per FDA).
- Experience with medical device design controls per EN ISO 13485:2016 or FDA
- Experience with medical device risk management per EN ISO 14971:2012
- Experience in Lab Supply or equivalent experience required at a minimum
- Need an awareness of regulations / legislations
- Ability to analyse, interpret regulatory requirements and define necessary solution driven actions
- Attention to Detail- responsible for maintaining compliance and staying up-to-date on regulatory policies and briefing to several departments such as Local RA, QA, QC, Product Management and Operations
- Ability to develop innovative strategies and creative solutions within the regulatory context
- Ability to work independently and complete individual projects with minimal supervision
- Extended computer skills, SAP would be an advantage
- Fluent in English, any other EU language a plus
- The opportunity to gain experience in a global manufacturing company
- Work based on an employment contract - permanent contract
- Possibility of working in home office mode
- Impact on department's operational performance
- Work in an international environment
- Attractive salary
- Non-wage benefits package
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