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
#J-18808-Ljbffr…