Regulatory Affairs Specialist

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.

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you. 

As Regulatory Affairs Specialist at Varian you are accountable for the coordination and preparation of document packages for regulatory submissions from all areas of company as well as audits and inspections. You compile all materials required in submissions, license renewal, and annual registrations and maintain regulatory compliance for our products. You keep abreast of regulatory procedures and changes, may interact with regulatory agencies on defined matters, and recommends strategies for earliest possible approvals of clinical trials applications.

Main Responsibilities

Ensures compliance requirements according to 21CFR part 820, Regulation (EU) 2017/745, ISO 13485, and the company quality manual.

Ensures in close collaboration with design and engineering teams that all product realization processes are applied, and the product is compliant.

Specific Responsibilities

• Coordinate the efforts associated with the preparation of regulatory documents for international regulatory submissions
• Prepare and maintain technical documentation and certificates as necessary to obtain and sustain product approval
• Communicate with regulatory agencies and testing laboratories regarding submissions, compliance test requirements and testing, and follow-up of submissions under review
• Advise engineering project teams and manufacturing on regulatory and labeling requirements
• Extend and maintain the knowledge on existing and emerging international and local regulations, standards, or guidance documents
• Conduct gap analysis for new standards and regulations
• Analyze product complaints and make recommendations regarding their reportability

Desired Qualifications and Skills

• MSc. or BSc. degree in engineering/science/law
• Experience in international standards and government regulations
• Experience with medical devices, preferably in radiation emitting devices, or wireless communication is a plus
• Experience of working and communicating with different regulatory authorities and corresponding relationships is an additional plus that may complete your profile
• Excellent communication skills in English, in writing and verbally
• You are analytical, communicative and focused. You work in a structured way and have an eye for details. In addition, you can express your ideas and research in written form.
• You are used to working independently, open to discussing ideas and solutions with your colleagues.
• You thrive in an international work environment and in cultivating your contacts with partners in Europe and overseas.

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