Annette Bitz Email & Phone Number

Ballerup, Capital Region, Denmark

Responsibilities:* Direction setting for Ambu biosafety strategy, chemical compliance strategy and baseline for biosafety activities* Direction setting for sustainability focus in Ambu R&D and road map for sustainability activities * Management of the Global Biosafety and Sustainability team as head of team* Manage and prepare biological evaluations, biocompatibility and chemical tests for the Ambu products as Principal Biosafety Specialist* Setting the biosafety strategy

Copenhagen Area, Capital Region, Denmark

*Management of Biosafety as head of team. *Oversee and ensure proper task allocation and sufficient scientific level in compliance with relevant regulations*Manage and prepare biological evaluations, biocompatibility and chemical tests for the Ambu products as Principal Biosafety Specialist* Setting the biosafety strategy

Copenhagen Area, Capital Region, Denmark

Responsibilities:* Direction setting for Ambu Biosafety strategy and baseline for Biosafety activities* Implementation of ISO 10993, ISO 18562, FDA guidance, RoHS2, REACH etc. * Participate in cross-functional R&D development projects* Prepare biological evaluations, Toxicological risk assessments and biosafety sections in 510k submissions* Manage and coordinate biocompatibility and chemical characterisation testing* Plan, design and conduct pre-clinical studies… Show more Responsibilities:* Direction setting for Ambu Biosafety strategy and baseline for Biosafety activities* Implementation of ISO 10993, ISO 18562, FDA guidance, RoHS2, REACH etc. * Participate in cross-functional R&D development projects* Prepare biological evaluations, Toxicological risk assessments and biosafety sections in 510k submissions* Manage and coordinate biocompatibility and chemical characterisation testing* Plan, design and conduct pre-clinical studies, clinical investigations and elaboration of clinical evaluations* Prepare applications to competent authorities and ethics committees* Member of the global CSR team Show less

Copenhagen Area, Denmark

Responsibilities:* Participation in product development projects * Elaboration of Clinical evaluations* Elaboration of Biological Evaluations* Management of biocompatibility testing* Support of marketing and sales* Support of regulatory affairs, product registration and REACH* Project manager for implementation of RoHS2* Member of the Global CSR team and responsible for CORP phthalatepolicy

Copenhagen Area, Denmark

Responsibilities:• Elaboration of biological evaluations of medical devices• Toxicological risk assessment of substances and materials• Biocompatibility and chemical testings• Coordinating activities with CRO’s • Development of biosafety procedures

Copenhagen Area, Denmark

Responsibilities:• Challenging R&D processes to ensure “green” products. • Environmental assessment and life cycle screening of materials and products• Development of marked oriented environmental communication on products• Implementation of new legislation e.g. implementation of the packaging and waste directive• Development of corporate policies and guidelines e.g.corporate phthalate policy. Lead auditor environmental audits.

Copenhagen Area, Denmark

Responsibilities:• Driving force in development and implementation of the global environmental management system certified according to ISO14001• Coordination between a range of stakeholders with mutual interest • Training of staff in environmental awareness ( >500 persons). • Implementation of EHS systems at both Danish and foreign sites including India.• Green accounts and obtaining environmental approvals for sites.

Copenhagen Area, Denmark

Responsibilities:• Competence person on hydrophilic coatings and cleaner technologies• Product specifications based on requirements from users and professionals• Project management• Project plans, test methods, clinical studies and production ramp-up• Material substitutions

Master'S Degree, Environmental Mangement

Project Management, Quality Management

Bsc, Chemical Engineer