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Regulatory Affairs Specialist

4 months ago

Tarrytown, United States Siemens Healthcare Diagnostics Inc. Full time

Do you wantto join us in helping to fight the world’s most threatening diseases andenabling access to care for more people around the world? At SiemensHealthineers, we pioneer breakthroughs in healthcare.For everyone. Everywhere.

We offer youa flexible and dynamic environment with opportunities to go beyond your comfortzone in order to grow personally and professionally. Sound interesting? Thencome and join our global team as Regulatory Affairs Specialist to supportinternational registrations .

Our globalteam : We are a team of 66,000 highly dedicated employeesacross more than 70 countries passionately pushing the boundaries of what’spossible in healthcare to help improve people’s lives around the world. As aleader in the industry, we aspire to create better outcomes and experiences forpatients no matter where they live or what health issues they are facing. Ourportfolio, spanning from in-vitro and in-vivo diagnostics to image-guidedtherapy and innovative cancer care, is crucial for clinical decision-making andtreatment pathways.

This is a role well suited to anambitious professional, looking for the next step in their career. As a Regulatory Affairs Specialist, you will be responsible for :

Preparing, submitting, and managing regulatory applications required for product market approvals in global market. Preparing, submitting, and managing Technical Files in compliance with the requirements of the local regulatory and the Quality Management System. Prepare, submit, and manage FDA PMA Annual Reports, FDA PMA 30-day notices or other supplements, 510(k) notes to file, 510(k) submissions, Notified body Annex II notifications, notification in line with IVDR requirements, other notifications other notifications. Acting as a Regulatory Affairs subject matter expert on new product introduction and design control teams. Participating in internal and external quality system and design dossier audits

This positionmay suit you best if you are familiar with what is below,and would like to dodevelop your career with Healthineers

Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance. Knowledge of IVD products and applicable regulations for such products You have very good presentation skills, and you show team orientation and communication skills. Ensure cross-functional collaboration and cooperation. Excellent attention to details. Able to multi-task and work effectively in a dynamic environment.

Required skills to have for the success of this role

Bachelor’s degree in scientific discipline Minimum of 5 years of experience in IVDs or Medical Device. Skilled in Outlook, SharePoint, Adobe Acrobat and Microsoft Office applications, including Excel Intercultural sensitivity Strong attention to detail and excellent organizational skills

This information is provided per therequired state Equal Pay Act. Base pay information is based on market location.Applicants should apply via Siemens Healthineers external or internal careerssite.

At SiemensHealthineers, we value those who dedicate their energy and passion to a greatercause. Our people make us unique as an employer in the med-tech industry. Whatunites and motivates our global team is the inspiration of our common purpose:To innovate for healthcare, building on ourremarkable legacy of pioneering ideas that translate into even betterhealthcare products and services. We recognize that taking ownership of ourwork allows both us and the company to grow. We offer you a flexible anddynamic environment and the space to move beyond your comfort zone to grow bothpersonally and professionally.

Beware of JobScams

Please bewareof potentially fraudulent job postings or suspicious recruiting activity bypersons that are currently posing as Siemens Healthineers recruiters/employees.These scammers may attempt to collect your confidential personal or financialinformation. If you are concerned that an offer of employment with SiemensHealthineers might be a scam or that the recruiter is not legitimate, pleaseverify by searching for the posting on the .

“Successful candidate must be able to work with controlled technology inaccordance with US export control law.” “It is Siemens Healthineers’ policy tocomply fully and completely with all United States export control laws andregulations, including those implemented by the Department of Commerce

Equal Employment Opportunity Statement
Siemens 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.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, .

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, .

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