If 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 requirements
* To advise on product regulation requirements for non-standard product development
* Ensure 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 bodies
* To coordinate the creation of the Product Technical files by Engineering
* To carry out or coordinate Product compliance and safety risk assessments
* Preparation and communication the strategy, challenges and goals for Product Regulation management including continuous improvement initiatives
* Reporting to management on the status of Product Regulation
Ancillary Responsibilities
* Ability to travel, nationally or internationally, as required or needed.
* Providing advice on other, non-X-ray, products where required
* Other activities and projects that can be expected.
Qualifications
* Degree in an Engineering discipline
* Experience in a Product Regulation role with standards and regulations including:
* EN 60204-1: Safety of electrical equipment of machines
* EN 61326-1: Electromagnetic compatibility
* EU Machinery Directive
* UL requirements
* RoHS, REACH
* Experience in communicating across cultures, and across organisations
* Experience in a Systems, Electro-mechanical device manufacture / design environment
* Experience in regulatory and compliance assessment and implementation
* Ability 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 business
* Experience 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 Competences
* High sense of responsibility and initiative
* Ability to work with minimum supervision
* Able to cultivate strong customer relationships
* Results driven and pragmatic
* Willing to be hands‑on with a ‘go and see’ approach.
* Strong organizational skills and a problem‑solving attitude
* Excellent listening and negotiation skillsAbility to travel
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