Regulatory Consultant – Medical Devices and Borderline Products

Closing date: 1 March, 2019

​Summary

Yordas Group is expanding and demand for our services is ever-growing. We are on the lookout for a hardworking and professional regulatory consultant in the area of Medical Devices, Medicinal Products and Borderline Products.

The successful candidate will work as part of the Regulatory team of the business, and in collaboration with project managers and consultancy staff. Depending on experience and interests, you will support companies with registrations of delivery devices/API combination in North America. The successful candidate will undertake client-driven activities as directed by the business and must be able to effectively and efficiently communicate with colleagues, clients, international partners and the authorities.

Roles and Responsibilities

  • Acting as account manager for the North American market, specifically Canada, the USA and Mexico
  • Providing regulatory guidance and developing compliance strategies for industry and our partners according to North American legislation
  • Supporting the development of regulatory strategies and deliveries of client products and coordinating with regulatory authorities
  • Providing gap analysis based on regulatory requirements and presenting options to mitigate risk
  • Assisting clients to trade internationally by facilitating the delivery of registrations and regulatory notifications through Yordas Group’s in-country offices and partners
  • Taking a key role in the delivery of services including the preparation, implementation and coordination of regulatory projects with support from the scientific and regulatory teams
  • Communicating clearly and effectively with colleagues, clients, the authorities and Partners across multiple time zones
  • Project managing and supporting the development and delivery of new business opportunities in North America by working closely with the business development team
  • Supporting and furthering the development and delivery of Yordas training solutions in the field of North American medical device and borderline product regulations

Profile and Qualifications

Required

  • A scientific background and university degree (MSc or PhD in Environmental or Medical Sciences, Chemistry, Biology, or equivalent)
  • Knowledge of the relevant medical device legislation for North America (FDA PMA in USA and TPD in Canada)
  • Experience in identifying and determining regulatory obligations in relation to medicinal products and borderlines and borderline medical products and accessories, such as: cosmetics, personal protective equipment, biocides, etc.
  • An active interest in pursuing a career in consultancy
  • An ability to learn, assimilate and effectively communicate information to support colleagues, discuss with partners and advise clients of regulatory requirements
  • Be able to work effectively with colleagues in other global offices
  • Excellent interpersonal skills, service-oriented personality and attitude
  • Strong organisational and presentation skills
  • Ability and willingness to travel to train and consult with colleagues in other global offices and attend and present at (inter)national conferences
  • Excellent language skills in English

Desirable

  • Some knowledge of other regulatory legislation, such as European MDD / MDR / IVDR etc.
  • Prior experience of managing projects and supporting teams to achieve their objectives is an advantage
  • Language skills in French and/or Spanish would be an asset

Click here for full Role and Person Specification

Applications with a covering letter and CV to recruitment@yordasgroup.com