Regulatory Affairs Specialist

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Regulatory Affairs Specialist to support international registrations.

Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture: 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. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.

This is a role well suited to an ambitious 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 position may suit you best if you are familiar with what is below, and would like to do develop 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

The pay range for this position is $92,496- $127,182 annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is 8% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html

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

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

Beware of Job Scams

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

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

"Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, 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, Click here.

Pay Transparency Non-Discrimination Provision

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

California Privacy Notice

California residents have the right to receive additional notices about their personal information. To learn more, click here.