- Sector: Manufacturing & Materials
- Function: Product design and development
- Contact: Matthew Heath
- Contact Email: firstname.lastname@example.org
- Contact Phone: 01384 446187
- Expiry Date: 03 November 2021
- Job Ref: 57108
Lead Compliance Specialist - Medical Devices
Our Client is a global technology enterprise providing new inventions that defy convention and simply work better. Based on their growth in new technologies including medical devices and other similar products for cosumer and non-consumer applications, they are seeking a senior level Lead Compliance Specialist to ensure that our Clients' 'Compliance & Approvals' (C&A) team ensures that all their current and future products meet the legal requirements for all countries of sale, gaining the necessary approvals or registrations in the appropriate time frame.
The regulatory Intelligence sub-team is further responsible for Identifying, keeping up to date with and communicating the regulatory, compliance & approvals route to Market for all projects while assessing any associated risks.
Accountabilities and Summaries:
We are seeking an experienced lead regulatory specialist in order to support our Clients' continued innovation in exciting new categories.
- The successful candidate will have knowledge and experience of leading compliance activities of medical and personal care devices including the use of the IEC 60601 family of standards. The lead regulatory specialist will be responsible for identifying the global regulatory requirements that our Clients' products shall comply with and shall advise on the implementation for all products, with an emphasis on new categories.
- The lead regulatory specialist will have an understanding of global regulatory and standards structures, maintaining knowledge of any relevant updates or changes and may represent our Clients' interests internationally when required.
- It is the responsibility of our lead regulatory specialists to mentor junior members of the team and to be a resource in their field of excellence for the global C&A team, ensuring that knowledge is captured and communicated in an appropriate manner.
- To compile the global compliance strategy and relevant requirements for any Client product with a focus on new categories.
- Ensure all compliance risks are identified and effectively communicated to the relevant teams.
- Give specific design guidance to designers based on requirements from the relevant standards or legislation.
- Liaise with Client markets around the world to manage specific product approvals when required.
- Mentor junior members of the regulatory intelligence team.
- May represent our Client in relevant standards committees or to regulatory bodies.
- Ensure knowledge is captured and communicated effectively and in a timely manner.
- Degree or equivalent in a relevant technical subject.
- Good communication skills both oral and written to all levels of the business. Able to present complex subjects simply and clearly to the target audience.
- Experience with global medical and personal care legislation is required with experience of using the IEC 60601 family of standards
- Passion and agility to work in a diverse and agile environment
- Competitive and executive salary level.
- Exposure to a broad and diverse range of our Clients' activities from research through to manufacturing and global sales for Client projects
- Career development and growth in a global team
- Discounts on inhouse machines
- Subsidized café and restaurants
- Free on-site parking
- Sport centre
- Life assurance
- Performance related bonus
- Pension scheme
- 27 days holiday plus eight statutory bank holidays
If you feel you have the experience and interest to work within this organisation which is focused on product innovation, then please apply directly or contact Matthew Heath (email@example.com)
Future communication and discussions maybe subject to NDA in advance.
Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Recruitment are those of an Employment Agency.