Medical Device Expert
The Medical Devices Expert is responsible for activities requiring in-depth knowledge of regulations and regulatory requirements in relation to Medical Devices post CE approval, as well as assessments of Medical Devices and In-vitro Diagnostic and Active Implantable Medical Devices (if appropriate) in Due diligences, this includes:
- Providing subject matter expertise to Brand Teams and cross functional Medical Device project team
- Providing internal training on Medical Device regulatory requirements to internal stakeholders
Providing Subject Matter Expertise in conjunction with due diligence of business opportunities
Interpret regulations and make recommendation on the implementation and the preferred regulatory strategy
Participate in external and internal audits to ensure the successful re-certification of products
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
- Maintain up to date knowledge of relevant regulations, guidelines and industry standards, proactive communicate to internal stakeholders in writing and presentations to disseminate and discuss the interpretation and implementation
- Provide expert advice and support to Brand Teams, cross functional Medical Device project team, and other area of the business, and communicate any changes required to Medical Devices RA Manager
- Provide expert advice and support to due diligence activities as requested
- Explore opportunities for continuous improvement to enhance business performance
- Interrogate and sanity check audit preparation, and participate in internal and external audits to ensure and sanity check successful re-certification of products.
- Participate in industry forums
- Provide training of Medical Device cross functional project team members in Medical Device requirements as deemed relevant
- Provide back-up support when RA Manager is not available.
INDIVIDUAL REQUIREMENTS AND COMPETENCIES
- Effective negotiation and influencing skills
- Ability to analyse and interpret complex issues and develop strategies and communication plans to resolve
- Clear communicator, sharing information to ensure successful partnering with internal and external stakeholders. Listens and responds effectively to others
- Responds quickly and positively to customer needs, develops effective collaborative working relationships with customers/external partners
- Shows strong respect and collaborative working with internal and external customers
- Aspires to continuously develop technical/professional knowledge and interpersonal/management expertise to be a good role model.
- Displays commitment and takes responsibility for personal performance and self-development
- Displays integrity, discretion and confidentiality when communicating with others, exhibits sound judgement
- Seeks and accepts responsibility to enhance overall business performance
- Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
- Able to contribute to budget preparation and review
- BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
- Must have expertise in the development, certification and maintenance of medical device products