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Medical Device Regulatory SME

Remote, IL 60515

Posted: 10/25/2022 Employment Type: Direct Hire/Perm Job Category: Regulatory Sciences and Medical Writing Job Number: 511739 Is job remote?: Yes Country: United States

Job Description

We provide clients with consulting, services, and solutions to support their  regulatory affairs operations and strategy. We help companies ensure regulatory compliance across  the globe by providing fully trained resources who understand the regulations and can leverage  this knowledge to assist our clients in their day to day operations.

Our vision is to be the premier niche provider of Regulatory Affairs services to improve  outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory  solutions that enable life science organization to deliver exceptional patient value.
About the Role:

  • Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. 
  • Master’s Degree is preferred.
  • RAC certification: Medical Devices is a plus.
  • Minimal 5 years of working experience in medical devices through positions in industry,  consultancy, or regulatory agencies (Notified Bodies, FDA, EMA), in either manufacturing,  R&D, quality, or regulatory roles. 
  • A proven track record for driving quality/compliance improvements across all levels and  functions
  • Experience in MDR remediation projects, writing MDR compliant reports and documents
  • Successful contribution to the regulatory approval of 510(k)s and product registration in  the EU and other countries 
  • Knowledge of Quality Management System and ISO 13485
  • Regulatory Affairs compliance and QMS assessment of Technical Files
  • Knowledge of Risk Management Systems based on ISO 14971: 2012
  • Experience in creating customer-facing materials and conducting workshops as SME
  • Knowledge of Medical Device Regulations related to major health authorities of US, EU,  Japan, China, Australia, Brazil, Canada
  • Fluent in English
Technical / Functional Skills:
  • Excellent knowledge of MDD/MDR and experience in writing plans and reports like CEP,  CER, PMCF Plan, PMCF Report, PMSR, PSUR, SSCP, etc. 
  • Excellent knowledge of ISO 13485 standards
  • Good understanding of IMDRF requirements for member countries 
  • Strong stakeholder management experience
Non-Technical Skills:
  • Possess strong verbal and written communications skills, strategic thinking, ability to  influence others & problem resolving skills
  • Good knowledge of strategy development and implementation techniques for Medical 
  • Device registrations, compliance towards new regulations, etc.
  • Possess strong verbal and written communications skills, strategic thinking, ability to  influence others & problem resolving skills
  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Project management and tracking
Personal Traits: 
  • Positive Attitude
  • Initiative and Commitment 
  • Leadership Skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance
Roles & Responsibility: 
  • Maintain, develop, and share your expertise and knowledge on a specific expert area and  participate in MDR related forums to understand the latest trends as well as approach 
  • prospective clients
  • Actively participate in client bid defense meetings for Medical Device prospective projects
  • Provide advisory consulting services, proactively monitor regulations across regions to  advise companies on new regulations
  • Provide SME consulting in the areas of regulatory strategy, submissions, and operations
  • Support building (technical) documentation and design dossiers in support of CE marking,  510(k), or other approval procedures
  • Provide SME consulting for Regulatory compliance according to the current EU Directives (i.e., MDD & IVD), new EU Regulations MDR & IVDR (EU 2017/745 & EU 2017/746), FDA,  ANVISA, Health Canada, MHLW/PMDA & TGA (MDSAP requirements)
  • Lead MDR gap analysis projects and conduct an analysis of existing systems, processes, and  departments in terms of new regulation
    • Implement improvements to technical files and other documents like Clinical  Evaluation Plan (CEP), Clinical Evaluation Reports (CER), etc. 
    • Understand current compliance situation of the medical device for international  standards
    • Suggest and support the implementation of changes to the organization’s risk  management processes
    • Develop device risk assessments with input from clinical and technical experts within  the organizations
    • Identify actions required to ensure compliance with ISO 13485, MDSAP, and MDR
    • Support and conduct updates to labeling, SOPs, work instructions, trending tools, and policy documents to ensure compliance with EU-MDR
    • Make updates to labeling, SOPs, work instructions, and policy documents to ensure  compliance with the client’s corporate SOPs
  • Assist in the development/construction of Technical Files according to the new MDR & STED  format with emphasis on developing the following documentations:
    • Essential Requirements Evaluation Report to Annex I of MDR & IVDR
    • Risk Management Reports / Documentation to ISO 14971: 2012
    • Clinical Evaluation Report development according to MDR & IVDR and/or MEDDEV  2.7.1 Rev 4
    • PMCF Plan and Report development according to MDR & IVDR and/or MEDDEV 
    • Development of Vigilance Reporting strategies to MDR & IVDR and/or MEDDEV 
  • Support regulatory submission projects with submission requirements for appropriate  market and product type
  • Establish and maintain a professional and credible relationship with direct clients (customers) and indirect clients like Health Authorities, Notified Bodies, and other  regulatory agencies.
  • Responsible for the operational planning of the project and prepares weekly plans for the  team which are in line with the project timelines
  • In collaboration with Quality Assurance, ensure that project team members are  appropriately trained on all project SOPs, guidelines, and documents as required. 
  • Proactively follow the news and trends in the market to share with the rest of the team.
  • You may be asked to support marketing activities, such as webinars, blog writing, as well as  business development activities such as presales meetings with prospective clients
  • Supporting internal and external audits as required
  • Provide status reporting to stakeholders according to an agreed communications plan
*CO candidates may not be considered
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