Regulatory Engineer

Overall job purpose:

To obtain and maintain all country specific regulatory clearances for Cyden devices to comply with the individual country regulations. 

Key Responsibilities:

Core Regulatory Tasks & Submissions

·       Broad worldwide knowledge IPL Medical Device status – Cyden MD submission and clearance records.

·       Determining country specific MD requirements for submissions.

·       US - FDA classification, submission, registration & GUDID.

·       Health Canada classification, submission & registration.

·       South Korea classification, submission & registration.

·       EU MDR classification, submission, registration and EUDAMED.

·       China NMPA classification, submission, registration and database.

·       Annual MD Registrations for each MD territory.

·       Maintain global regulatory certifications for existing device lines.

·       Notified changes, change control to Notified Bodies (NB’s).

·       Legalization of documents for regulatory submissions.

·       Preparing device samples for regulatory submissions.

·       Determining regulatory artwork requirements device type plate requirements, sales box and user instructions (regulatory markings & logos).

·       Establishment and maintenance of regulatory specific device market approval records, including MDSAP / ISO13485 / EU MDR / China NMPA auditee.

·       Comply with Cyden’s Regulatory procedures, including MD country specific procedures.

·       Review and approval Cyden artworks (sales box, IFU, type plate).

·       Review and approval of Cyden’s Customer Requirements Form (CRF).

·       Compiling environmental data for waste regulations. WEEE licence UK & Europe.

Project Management & Communication

·       Manage regulatory department schedule and regulatory engineering tasks.

·       Develop Critical Path Schedules (CPS) and summarize using the regulatory ‘Advanced Quality Planning Process’ (APQP) templates.

·       Supporting Development team to compile regulatory input for the Technical Files for each device platform.

·       Ability to run Cyden regulatory requirement project meetings with Development team. Typically weekly.

·       Ability to run Cyden regulatory requirement project meetings with Cyden customers. Typically weekly.

·       Ability to run Cyden regulatory requirement project meetings with overseas consultants.

·       Support the Cyden ‘Go To Market’ (GTM) project meetings for new platform launches.

·       Regulatory Networking. Outward facing industry learnings.

Regulatory Product Testing (Outputs)

·       Establish and maintain device platform regulatory test requirements instruction. Define testing requirements to comply with the latest applicable test standards.

·       Provide the regulatory marking and labelling requirements for device and product artworks.  

·       CB Submission.

·       EMC Submission.

·       MET and other non MD submissions.

·       Working directly with UK test laboratories (contact/quote/budget/schedule).

·       Satisfying worldwide testing requirements (contact/quote/budget/schedule).

·       Declaration of Conformity (DOC): UK, EU, Aus, US(FCC), Hong Kong etc.

These tasks are not intended as an exhaustive list of the post holder’s duties. The post holder is expected to carry out any reasonable request as deemed appropriate by their Line Manager to support business needs. Specific responsibilities and authorities are defined in procedures relevant to the role.

Experience:

Essential

·       Project management experience within Electrical/Electronic industry

Desirable

·       Regulatory management experience within medical devices

·       Working knowledge of ISO 13485/MDSAP/MDD changing to EU MDR

Qualifications and training:

Essential

·       HNC/HND Electrical/Electronic Engineering (Undergraduate)

Desirable

·       A degree in a relevant scientific discipline, or equivalent experience

Other attributes:

·    Excellent written and verbal communication skills

·       Excellent accuracy and attention to detail

·       Capable of working on multiple projects, both independently and in a team environment

·       Able to critically evaluate and summarise complex data into simple messages and actions

·       Prepared to build networks and alliances with peers and external partners

·       Efficient, well organised with a systematic and methodical approach to work

·       Positive and motivated attitude