Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

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locations

Remote – US

Remote – Ontario, Canada

time type

Full time

posted on

Posted Today

job requisition id

R-20701

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 you will be responsible for developing strategies for worldwide governmental approval to introduce new products to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions and negotiate their approval with the agencies. In addition, this position also assists with the training of other regulatory affairs associates.

What You will do:

• Perform the coordination and preparation of document packages for regulatory submissions for brachytherapy devices and radiation treatment planning software as well as internal audits and inspections.
• Compile all materials required in submissions, license renewal and annual registrations.
• Provide input and review for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Keep abreast of regulatory procedures and changes.
• May directly interact with regulatory agencies on defined matters.
• Recommend strategies for earliest possible approvals of marketing and investigational applications.
• Write and maintain submissions procedures, work instructions, and templates.

What You will have

• Typical Education and Experience: Bachelor’s degree (or equivalent experience) and 8 years of related experience or Master’s Degree with 6 years of related experience in an engineering, clinical, scientific, or technical writing field.
• Product Registration Experience: Experience with FDA 510(k) application and Q-submissions, Health Canada license applications and EU MDR files for brachytherapy devices and radiation treatment planning software. Knowledge of biocompatibility, sterilization and shelf-life regulatory requirements.
• Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
• Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.

#LI-Remote

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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Equal Employment Opportunity Statement

Varian is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.