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

Employer
Mosaic Regulatory Solutions
Location
Homeworking
Salary
Excellent
Closing date
10 Oct 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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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

Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.

Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.

We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.

Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.

Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.

Contact Us
  • Blackheath
  • SE3
  • GB
  • 07951 082482
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