Regulatory Affairs Specialist (m/f/d) - Proton Therapy Cancer Treatment

Jobinhalt

Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world’s best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. If you want to be part of this important mission, we want to hear from you.

The Proton Solutions business develops, designs, manufactures, sells and services products and systems for delivering proton therapy, another form of external beam therapy using proton beams, for the treatment of cancer.

This role is to be filled in Europe - Remote.

Major Responsibilities

• Handles pre-market activities such as medical device product registration as well as establishment registration licenses
• Establishes and maintains a successful relationship with the different regulators
• Participates in relevant organizations and associations advocacy efforts involved in legislation and standardization to represent VPS interests.
• Participates in various task force activities related to new/changed regulatory requirements
• Organizes pre-market registration activities such as medical device product registration as well as medical device establishment registration licenses including:
• Identifies and interprets applicable regulatory requirements
• Compiles submission dossiers
• Communicates and interacts with regulatory authorities
• Maintains regulatory clearances including notification of significant changes to relevant authorities
• Provides expertise in translating regulatory requirements into practical, workable plans.
• Keeps up to date with developments in technologies regulations and standards relating to the company’s products
• Provides training to internal colleagues regarding regulatory requirements applicable to Varian Proton Solutions
• Provides internal support to colleagues e.g. Sales, Service, Engineering, Product Management.
• Applies a risk based approach and sound decision making in order to enable earliest possible market clearance.
• Reports on regulatory status/progress as well as updating regulatory licenses before they expire.
• Supports regulatory inspections at Varian related to the medical device
  

Required Qualifications

• Bachelor’s Degree in Computer Science, Engineering or related technical field preferred.
• Ideally a several years of medical device background/experience in related field e.g. Regulatory Affairs, Quality Assurance, Service, Installation, Engineering
• Experience of working in a high technology design and manufacture environment in a regulated industry. Strong ability to influence and motivate people, having good business sense coupled with a mature and tactful approach.
• Experience in working and communicating with different regulatory authorities’ requirements (e.g. US FDA, NMPA in China, EU notified body, EU Competent Authority, etc) and corresponding successful relationship management with the regulators preferred.
• Ability, competence, and confidence to interact with people.
• Effective interpersonal and communication skills.
• Basic knowledge about standards and government regulations applicable to medical devices e.g. ISO 13485, 21 CFR 820 QSR, MDSAP, ISO14971, IEC 60601 series of applicable standards, EU MDR 2017/745 , MDD 93/42/EEC, FDA 510(k) premarket notification process and NMPA regulation in China,
• Experience in radiation regulation related to radiation emitting machines a plus.
• Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint and Teams
• Experience with SAP or equivalent ERP product and productivity software desired.
• Conversant with the practical requirements of MDSAP, ISO13485, ISO14971, IEC 60601 series of applicable standards, EU MDR 2017/745 , FDA 510(k) premarket notification process and NMPA regulation in China.
  

Watch this short Video on Varian Proton Solutions in Germany: visit the Manufacturing Site, walk through the Offices, meet future colleagues and feel the atmosphere of life at Varian in Troisdorf, Cologne area! Together, we imagine a world without fear of cancer. Join us!

Talent Video On LinkedIn

https://www.linkedin.com/feed/update/urn:li:activity:6636704196106293248

OR YouTube

https://www.youtube.com/watch?v=yBgrYW68G-U

#MyVarianWhy Video:

https://youtu.be/IXPT2rZC1UA

ProBeam Video - How is proton therapy planned and carried out?

https://www.youtube.com/watch?v=fEdHGjRnpzk

Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.

Fighting cancer calls for big ideas.

We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That’s why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.

#TogetherWeFight

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