Regulatory Affairs Specialist

this role, you have the opportunity to 
 guide and support the EU MDR Program and the Business Groups in EU regulations. This involves being a confident advisor on 
 regulatory strategy, lobbying, regulatory compliance and quality management related topics, in order to achieve systems and 
 product compliance to the EU MDR by May 2020 and IVD by May 2022 as well as to support other laws, regulations and 
 standards impacting safe and effective utilization in the EU. 
 Your responsibilities will include but are not limited to the following: 
 • Own and drive activities within the EU MDR Program as a Subject Matter Expert. Define and support training with 
 information/guidance documents on MDD/MDR/IVDR/MEDDEV 2.7/rev4 as appropriate within the businesses and 
 supporting functions. Consultation on MDR/IVDR (internally & externally) to drive position and maintain awareness 
 of industry (competitor) positioning 
 • Help identify key priorities and decisions to enable the organization to capture key opportunities to reduce risk and 
 improve performance on implementation of EU MDR/IVDR Program 
 • Monitor the implementation of the new EU MDR/IVDR requirements and identify any key risk areas and mitigation 
 activities within business and supporting functions to ensure compliance prior to May 2020 and May 2022 deadlines. 
 • Support standards team on analysis, interpretation and dissemination of information as it applies to the EU MDR. 
 • Serve on national and international standards committees and industry organizations that establish or influence 
 requirements on medical products/solutions (i.e. Participate in COCIR and MedTech Europe representing Philip and 
 Leadership in Key Committee(s) representing industry) 
 • Leverage well developed interpersonal skills to build and maintain positive working relationships with functional groups 
 throughout the organization 
 • Support internal program and external communication, which includes content and planning for communications 
 cascades, and supporting review / feedback. 
 
 The role reports solid line to the EU MDR / IVDR program director within GR&S and dotted line to the Head of Global Regulations 
 & Standards 
 To succeed in this role, you should have the following skills and experience 
 Bachelor’s degree in science,engineering/technology or related field, Master’s degree preferred.· 
 Min 7+ years of experience with working knowledge of global medical device regulations, requirements· 
 Viewed as an expert within EU Regulations, with proven experience in implementation and use of EU Medical Device· 
 Directive, In Vitro Diagnostic Directive, Low Voltage Directive and Radio Equipment Directive and knowledge and 
 interpretation of the differences in the EU MDR Medical Device Regulations. 
 Knowledge and expertise in Quality Management Systems and Risk Management Standards – ISO 13485 and ISO 14971.· 
 Strong executive presence; ability to influence multiple levels of stakeholders and management· 
 Demonstrated track record of team leadership, building teams, relationship management, and business development,· 
 including virtual teams 
 Strong communication, interpersonal and presentation skills; detail-oriented· 
 Proven experience in a matrix management of multiple operations· 
 Ability and willingness to travel both domestically and internationally up to 25% of the time 

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