Head of Product Regulation
Job Description
Head of Product RegulationIf you're looking to join a company with a dynamic vision for the future, set your sights on a challenging career with Nikon Metrology.
We develop a wide range of measurement systems for dimensional quality control deployed worldwide in automotive, aerospace, and other manufacturing industries.We are looking for an experienced and enthusiastic Head of Product Regulation, X-ray based at Nikon X-Tek in Tring, Hertfordshire UK.What is the role?
The position is responsible for both strategic and operational leadership of Product Regulation for Nikon X-ray CT product to Nikon Corporate, Business Unit, Regional and International (ISO) regulations.
This role reports into the Nikon X-Tek design and manufacturing site but also has responsibility to support a second design and manufacturing site as well as Sales Regional organisations.Key areas of responsibility To be the subject matter expert for the appropriate regulations and their interpretation.Provide authoritative and clear guidance throughout the device development and manufacturing process to ensure timely development and manufacturing of products that meet applicable quality and regulatory requirementsTo advise on product regulation requirements for non-standard product developmentEnsure compliance with the Laws and regulations on safety, such as product labelling (CE, UKCA, etc.).Ensure compliance and submission of data for chemical substances in products (such as RoHS, REACH and Nikon Corporate’s own Green Procurement Standards).Coaching, mentoring and training business stakeholders regarding matters related to Product Regulation.To be able to provide quick regulatory advice on requests to stakeholders, including the Sales organisations.To lead investigations and actions should any case of noncompliance be raised internally or external to the company.To be the point of contact, representative and influencer on product regulation for the company with Nikon organisations and external regulatory bodiesTo coordinate the creation of the Product Technical files by EngineeringTo carry out or coordinate Product compliance and safety risk assessmentsPreparation and communication the strategy, challenges and goals for Product Regulation management including continuous improvement initiativesReporting to management on the status of Product RegulationAncillary ResponsibilitiesAbility to travel, nationally or internationally, as required or needed.Providing advice on other, non-X-ray, products where requiredOther activities and projects that can be expected.Qualifications EssentialDegree in an Engineering disciplineExperience in a Product Regulation role with standards and regulations including:EN 60204-1
Safety of electrical equipment of machinesEN 61326-1
Electromagnetic compatibilityEU Machinery DirectiveUL requirementsRoHS, REACHExperience in communicating across cultures, and across organisationsExperience in a Systems, Electro-mechanical device manufacture / design environmentExperience in regulatory and compliance assessment and implementationAbility to proactively get involved as a team member on issues of product compliance.Experience of building, establishing and maintaining collaborative relationships - cross-functionally, within own team and with colleagues and leaders across a businessDesirableSystems Engineering ExperienceExperience with X-ray systems and regulation worldwide including EN IEC 61010-2-091
Requirements for cabinet X-ray systems and UK Ionising Radiations Regulations 2017 requirements.Functional CompetencesHigh sense of responsibility and initiativeAbility to work with minimum supervisionAble to cultivate strong customer relationshipsResults driven and pragmaticWilling to be hands-on with a ‘go and see’ approach.Strong organizational skills and a problem-solving attitudeExcellent listening and negotiation skillsAbility to travelWhy Nikon Metrology?At Nikon Metrology, our success is achieved by our employees.
Clearly defined common goals, objectives, and priorities, create a foundation to work with pride and confidence.
Our employees highly value the supportive and collaborative working environment, and we share our passion for technology and innovation.Interested?Do you see yourself as our new Head of Product Regulation, X-ray?
Please send your covering letter and updated CV to or apply onlineWe look forward to your application!