Senior Regulatory Affairs Specialist

·         7+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II, Class III medical devices and software medical devices

·         Demonstrated experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers.

·         Experience in the use of clinical data to support regulatory submissions (e.g. expansion of indications)

·         Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus.

·         Strong ability to interpret regulations, identify regulatory data needs, and solve regulatory issues.

·         Ability to balance detailed execution with broader regulatory strategy development.

·         Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993.

·         Demonstrated ability to work independently and collaboratively in a fast-paced, ambiguous environment.

·         Strong judgment and comfort making regulatory recommendations under uncertainty.

·         Clear, concise verbal and written communication skills across diverse audiences.

·         Highly organized with strong prioritization and project management skills.

·         Proficiency in MS Word, Excel, PowerPoint, and Adobe.

·         Must be able to travel as needed

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$115,740 - $159,137

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

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

Export Control: “A 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 through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

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·         Experience with international filings (Australia, Japan, China, Latin America etc.)

·         Background in interventional oncology products, electromechanical devices and software in medical devices (SiMD/SaMD)