Reg Affairs Consultant - Medical Devices / Combination products- Remote - knowledge of CER/MDD/MDR

Medical Device Regulatory Consultant

Location: London / Remote

3 months contract then to perm role.

Must have following experience:

CEP/CER for combination products

Experience with  combination products for drug and device

This company is looking for a Medical Device Subject Matter Expert based in the UK, Europe, or the US to support with EU-MDR gap assessments, remediation activities for related documentation, and business development activities. 

Roles & Responsibilities

●       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

●       As a medical device expert, you will support to build (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, Heath Canada, MHLW/PMDA & TGA (MDSAP requirements)

●       Lead MDR gap analysis projects and conduct analysis of existing systems, processes and departments in terms of new regulation.

●       For MDR Gap Assessments you will perform the following: Work with stakeholders to identify required changes to compliance processes and updating associated process documentation including Technical, Quality, Clinical, Post-Marketing, Labeling, Economic Operators and other areas

o       Implement improvements to technical files and other documents like Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER)

o       Understand current compliance situation of medical device to international standards

o       Suggest and support implementation of changes to organization’s risk management processes

o       Develop device risk assessments with input from clinical and technical experts within the organizations

o       Identify actions required to ensure compliance with ISO 13485, MDSAP and MDR 

o       Supporting and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with EU-MDR 

o       Make updates to labelling, 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 following documentations:

o       Essential Requirements Evaluation Report to Annex I of MDR & IVDR

o       Risk Management Reports / Documentation to ISO 14971:2012

o       Clinical Evaluation Report development according to MDR & IVDR and/or MEDDEV 2.7.1 Rev 4

o       PMCF Planning Report development according to MDR & IVDR and/or MEDDEV

o       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 (customer of ) 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 time lines

●       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

Education & Experience

Education:

• 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

Experience:

• Minimal 5 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA, EMA), in either manufacturing, R&D, quality or regulatory roles
• Experience writing MDR compliant Clinical Evaluation Reports and other documents
• Knowledge of Quality Management Systems implementation to ISO 13485:2016
• 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
• Worked in a client-focused organization as a consultant in the past
• Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices
• Fluent in English

Skills and Competencies

Technical / Functional Skills:

• Excellent knowledge of MDD/MDR
• 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