Job SummaryThe Regulatory Affairs Product Compliance Specialist Consumables and Equipment will ensure the Business is timely informed on and support the implementation of the requirements on the latest changes in regulations addressing product safety and environmental requirements (LVD, EMC, GPSD, PPE, Waste Framework Directives, ROHS, SCIP etc) Identify and secure legal tracking tools (databases, newspapers, etc.
for the applicable legislation. Work within Regulatory Affairs team on other legislative areas (Personal Protective Equipment, Medical devices) POSITION PROFILE : (Basic Purpose of Position) The Regulatory Affairs Product Compliance Specialist Consumables and Equipment will ensure the Business is timely informed on and support the implementation of the requirements on the latest changes in regulations addressing product safety and environmental requirements (LVD, EMC, GPSD, PPE, Waste Framework Directives, ROHS, SCIP etc) Identify and secure legal tracking tools (databases, newspapers, etc.
for the applicable legislation. Work within Regulatory Affairs team on other legislative areas (Personal Protective Equipment, Medical devices) MAJOR JOB DUTIES AND RESPONSIBILITIES : (List in Order of Importance) Identify and follow up on upcoming and updated European legislation addressing product Safety and environmental requirements affecting our products by utilizing tracking tools and network Monitor and analyse EU Oj publications to identify any newly listed standards Draft and define, in cooperation with stakeholders, instructions and SOP’s with appropriate conformity actions for Business Advise and interact with Central Regulatory Affairs, Local Regulatory Affairs, Legal Department, European and local Quality Managers, Chief Scientist, Procurement, Sourcing, Central Planning, Logistics, Product Portfolio, Sales, Operations, Suppliers and Manufacturers.
Give input and work together with Portfolio Management, Sourcing, Suppliers and OEM to secure compliant products are placed on the market.
Advice Business, local Regulatory Affairs responsible, local sales / marketing in compliance matters (e.g requirements for new products, interpretation of regulations and standards, etc.
Act / report proactively when recognizing significant business risk for VWR. Assist local Regulatory Affairs Responsible in contacts with governmental bodies, towards Market Surveillance in case of non-compliance or any enquiry.
Maintain close relationship with other business groups ( e.g. Sourcing, Port Folio Management, Sales, QA etc) Monitor competitors and OEM practices to understand the market and assess the risks Participate in / lead product compliance related projects Support supplier / product on boarding, and supplier contract approval.
Work with the other Regulatory Affairs teams to advise on, and implement cross-functional topics Carry out / coordinate training of the local regulatory associates in Europe Support the business to resolve daily regulatory queries KNOWLEDGE SKILLS AND ABILITIES : (Those Necessary to Perform the Job Competently) Ability to collaborate in a multicultural environment Highly organized and good planning skills Need awareness, knowledge and interpretation skills for the various regulations and licensing in Europe Able to make / drive decisions and take responsibility for outcomes Consistent exercise of independent judgement and discretion in matters of significance Knowledge of SAP processes and extended computer skills Adaptive, flexible, strategic and change oriented Strong analytical and problem solving skills Customer centric with advanced communication skills Ability to define solution driven actions Willing to travel as required QUALIFICATIONS : (Education / Training, Experience and Certifications) A minimum Bachelor Degree in Sciences or product development.
3 years experience of Regulatory Affairs in CE marking Comprehensive understanding of legal requirements Knowledge of, or particular interest for the following legislation : New Legislative Framework (NLF), CE Marking, Safety (EU Low Voltage Directive (LVD), General Product Safety Directive (GPSD) and similar) Waste Framework Directives (WEEE, RoHS, Waste of Packaging) Proficiency in Microsoft Office tools and SAP (ERP) Fully proficient in Business English and, ideally, another language ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT : (Under Typical Positions) Some travel, as required.
Typically works in an homeoffice environment with adequate lighting and ventilation and a normal range of temperature and noise level.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis. Minimal physical effort is required. Work is mostly sedentary.
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