Principal Regulatory Affairs Specialist

<p style="text-align:left"><span>Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.</span><br /><br /><span>Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.</span></p><p style="text-align:inherit"></p>We are currently looking for an ambitious Principal Regulatory Affairs Specialist to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance, and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.<ul><li>Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe, Asia).</li><li>In collaboration with subject matter experts, independently prepare and author regulatory documents such as Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions (IDE), and pre-market notifications, such as De Novo.</li><li>Support and manage interactions with regulatory bodies (e.g., FDA, Notified Body)</li><li>Support Clinical Affairs (Research) in Clinical Evaluation Reports, Post Market Surveillance Reports as needed. Lead the reporting of these technical documents to regulatory bodies as required by internal quality procedures.</li><li>Participate and support new product development teams by defining regulatory requirements for product development along with ensuring adherence to internal Design Control SOPs;</li><li>Support clinical affairs and clinical operations as needed (i.e., periodic reporting of safety to regulatory agencies)</li><li>Support document change control activities that require regulatory approval.</li><li>Review validation protocols and reports to support regulatory submissions.</li><li>Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.</li><li>Ensure compliance with regulatory agencies and all applicable standards worldwide for legacy and new products.</li><li>Work on complex challenges that require in depth knowledge of regulatory principles and practices.</li><li>Other duties as assigned.</li></ul><p>Required skills to have for the success of this role:</p><ul><li>Bachelor’s degree in a scientific discipline required, Master’s degree or higher preferred.</li><li>Minimum of 15&#43; years’ experience in strategic Clinical and Regulatory Affairs tactical executions (including authoring regulatory submissions and demonstrating favorable outcomes such as regulatory approvals) a must;</li><li>Proficiency in ISO 13485, 21CFR820 (including Design Controls and Risk Analysis), EU MDR Regulation (EU) 2017/745 is a must.</li><li>Experience in medium to high-risk devices with, along with De Novo or PMA applications, and demonstrated approvals are a must.</li><li>Experience in generating, updating and managing Clinical Evaluation Plans/Reports and Post Market Surveillance Plans/Reports is a must.</li><li>Experience with authoring and managing Technical Files and Design Dossiers conforming with Europe’s Medical Device Regulation is a must.</li><li>Proficiency and experience in rest of world regulatory submissions requirements for premarket approvals or clinical trial authorizations (e.g., Asia, South America) are ideal.</li><li>Experience in project management and associated project management tools (e.g., Microsoft Project) is a must.</li><li>Knowledge and experience in clinical affairs including IDE submissions are ideal.</li><li>Experience with complex electromechanical, software controlled robotic systems, AI, SaMD, neuro devices is ideal</li><li>Experience with FDA inspection (QSIT) and Notified Body audits is required.</li><li>Experience with FDA BIMO inspection is ideal.</li><li>RAC-devices certificate preferred.</li><li>Ability and willingness to work in a lean, fast-paced environment.</li><li>Willing to travel up to 10%.</li></ul><div><div><div><p></p></div></div></div><p></p><p><b>Who we are</b>: 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.</p><p></p><p><b>How we work:</b> 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.</p><p></p><p>To find out more about Siemens Healthineers businesses, please visit our company page <a target="_blank" href="https://www.siemens-healthineers.com/en-us">here</a>.</p><p></p><p>The base pay range for this position is:</p><p></p>$147,760 - $203,170<p></p><p>Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.</p><p></p><p>If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company&#39;s plan. Commissions are based on individual performance and/or company performance. </p><p></p><p>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.</p><p></p><p><b>Equal Employment Opportunity Statement: </b>Siemens Healthineers 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.</p><p></p><p><b>EEO is the Law:</b> Applicants and employees are protected under Federal law from discrimination. To learn more, click <a target="_blank" href="https://www.dol.gov/agencies/ofccp"><span style="color:#0000ff"><u>here</u></span></a>.</p><p></p><p><b>Reasonable Accommodations:</b> Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.</p><p></p><p>If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form <a target="_blank" href="https://www.siemens-healthineers.com/en-us/careers/accommodation-for-disability">here</a>. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func&#64;siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status. </p><p></p><p><b>California Privacy Notice: </b>California residents have the right to receive additional notices about their personal information. 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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.</p><p></p><p><b>To all recruitment agencies:</b> Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. </p><p></p>