Head of Product Regulation
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
Essential
* 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
Desirable
* Systems Engineering Experience
* 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 skills
* Ability to travel
Why 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 recruitment.nm-uk@nikon.com or apply online
We look forward to your application!