Six month contract, full-time
Bristol, United Kingdom
Salary dependent upon experience
Start date: ASAP
We’re a Bristol-based bionics company developing affordable, assistive devices that enhance the human body. We've started by introducing the Hero Arm, a stylish multi-grip bionic hand. Current upper limb prostheses exist as hooks, grippers, or expensive bionic hands. We're on a mission to make beautiful bionic limbs more accessible. Visit our website to find out more: www.openbionics.com
We are expanding our compliance team. Your role as a compliance officer requires diligence, self-motivation and an ability to drive forward the company’s compliance culture and quest for excellence. You will be highly motivated to keep up to date with regulatory compliance issues, and effectively communicate these to colleagues in a timely manner. You will have the self-confidence to police compliance issues within the company.
Development of company regulatory compliance procedures.
Contributing to risk assessments of new products and processes.
Working with the engineering team to arrange third party compliance testing.
Conducting internal audits of product compliance. Internal policing of company compliance.
Drafting and signing off on compliance documentation.
Keep up to date with changes in regulatory requirements and communicate these to colleagues.
A minimum of five years’ experience working within a manufacturing company, preferably within a regulated sector such as medical, automotive or aerospace.
Experience of working with both hardware and software.
Experience of CE marking products preferably medical devices.
Experience in technical file production and review.
Experience conducting risk analysis.
Experience drafting and revising company policies.
Experience of defining manufacturing compliance processes.
Experience of regulatory compliance management to the requirements of at least three the following EU directives:
The Medical Devices Directive (93/42/EEC)
Machinery Directive 2006/42/EC
The Electromagnetic Compatibility (EMC) Directive 2014/30/EU
The Low Voltage Directive (LVD) (2014/35/EU)
The RoHS 2 directive (2011/65/EU)
WEEE Directive 2012/19/EU
Experience implementing and maintaining ISO 13485 compliance.
Working knowledge of EN 60601.
Understanding of the FDA requirements for medical devices.
Understanding of medical device regulations for Canada.
Understanding of the EU General Data Protection Regulation (GDPR).
Experience educating and training employees in regulatory compliance matters.