Exciting opportunity for an In-House Clinician
Intertek Semko Notified Body / Läkarjobb / Stockholm
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Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 43,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers' operations and supply chains.
Intertek 's business assurance team provides a comprehensive range of auditing and certification sevices ensuring that management system are optimized to facilitate successful growth. Products and services are only as good as the management systems that support them. Intertek provide the tools needed to evaluate and continually improve business processes. With a high level of technical expertise and a costumer-focused approach, they look beyond the standard to provides audit that add strategic value to a business.
About the role
The rola is a part time, home based role and will involve supporting Semko AB Notified Body AB and the Intertek Medical Notified Body AB (IMNB), in a range of clinical maters.
The Notified Bodies (wholly owned subsidiaries of Intertek) provides Conformity Assessments for a range of medical device families, including accredited third-party management systems auditing and certification.
The role has accountability to support the operation of the business by providing clinical oversight of clininical conformity assessments of the device Manufacturer 's clinical evidence to ensure compliance with the conformity assessments requirements set out in EU Council Directive 93/42/EEC, as well as the new Medical Device Regulation 2017/745 (MDR) in the near future. This will be performed in a timely and accurate manner, in accordance with documented procedures, forms and registers forming part of the Notified Body 's Quality Management System.
The role holder is also required to:
• Deliver training and advice to notified body staff;
• Provide clear, consistent and clinically sound reports and advice, appropiate for the specific recipient audience;
• Participate in meetings for training and liaison with external experts as well as addressing clinical concerns with manufacturers;
• Complete clinical reviews in a timely manner, within current regulatory requirements and for a wide range of medical device familis
Additional information
The role holder will be required to work part time to allow continuation of clinical practice.
About you
Required skills and experience
• A medical (MD) qualification and specialist training in a relevant medical specialty;
• A form of ongoing clinical involvement to ensure device knowledge is current;
• Meet and maintain appropriate registration requirements with a license to practice;
• Good IT literacy skills;
• Ability to work to set time frames once scheduled for a project
The ideal candidate will also have:
• Current knowledge and experience of using a broad range of medical devices, covering a wide range of NBOG medical device product families;
• An understanding of EU Regulatory requirements as applicable to the medical devices that SEMKO AB is accredited for and IMNB will be under the MDR;
• Experience in clinical investigation studies in the EU involving medical devices;
• Experience of giving internal advice on clinical matters related to novel features of devices, medical device vigilance, and medical device risk assessments.
Personal qualities
• Analytical
• Results driven to focus contribution on activities which meet company goals and deliver the greatest value
• Ability to critique and improve activities through continuous improvement and innovation
• The ability to demonstrate respect, equity and empathy for a diverse community
• Motivated, self-starter
• Encourage teamwork (promote operational synergies and alignment) to support each other, our customers and grow together
• Highly energised mindset with willingness and desire to learn and adapt individually
• Drive performance by ensuring performance expectations are met
• Fosters integrity and honesty
• Ensure compliance to company, industry and regulatory standards
• Ability to demonstrate exceptional customer service
• Highly organised with strong attention to detail
• Confident communicator (written/ oral) and able to build rapport, quickly and effectively
• Demonstrates flexibility and resilience to meet the demands of the role
• Able to act on own initiative
• Excellent time management
• Promotes company values to others and supports values in daily activities and decisions
How to apply
Please submit your application with your current CV and covering letter today. If you have any questions regarding the position, please contact Dr Erman Melikyan
erman.melikyan@intertek.comYour application must be in English as this is the operating language for Intertek corporation. All candidates will be required to confirm eligibility to work in the EU before starting employment.
Varaktighet, arbetstid
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Publiceringsdatum2018-12-11ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-01-16
Klicka på denna länk för att göra din ansökanFöretagIntertek Semko Notified Body
AdressIntertek Semko Notified Body
Torshamnsgatan 43
16440 Kista
KontorsadressTorshamnsgatan 43
Jobbnummer 4503471
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