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Who we are:
We are a team of more than 71,000 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. Check our Careers Site at www.siemens.com/careers.
Overview
The Head of Regulatory Affairs will lead the regulatory strategy and operations for a Point of Care business. This role requires an expert in medical device regulations, global market access strategy, and regulatory submissions (e.g., FDA, CE Mark). This role is responsible for ensuring that products meet all regulatory requirements and for executing a timely regulatory go-to-market strategy.
Position Reports To : President of Point of Care. Siemens Healthineers DX POC
Key Responsibilities
Serving as a key and active member of the POC leadership team, interacting with the team and other business functions to ensure objectives are aligned and that the company is performing to operational objectives.
Leading, coaching and mentoring the Regulatory organization ensuring appropriate levels of accountability for decision making and clearly communicate cross functionally within the organization
Providing management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide.
Tracking and maintaining product approvals and completes all necessary notifications, supplements, amendments, listings, and yearly reports for products on a global basis
Oversee the regulatory lifecycle management of products to ensure continuous compliance with all applicable regulations.
Collaborate with R&D and product development teams to integrate regulatory requirements into product design and development processes, facilitating smooth regulatory approvals and clearances.
Collaborate with the clinical team to align clinical affairs activities with the regulatory strategy.
• Providing counsel, training and interpretation and guidance on FDA, EU, China and other regulatory requirements to all company personnel.
Overseeing preparation and filing of all regulatory documents with the FDA and international regulatory agencies.
Developing and maintaining functional external relationships with FDA and Notified Body and other regulatory officials.
Ensuring current and ongoing Regulatory Intelligence information is provided with analysis of impact to the business.
Directing the development of systems, practices and processes to ensure effective ongoing review of product design and change requirements to ensure ability to launch new products into the market
Providing leadership and direction for significant deviation events that may impact compliance status or significant business risk.
• Represent the company at industry associations, regulatory meetings, and public forums to advocate for favorable regulatory policies and enhance the company's presence in the Point of Care sector.
Travel may be up to 30% for this position.
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
Demonstrated success in Regulatory Affairs, including oversight or submissions for new products and product changes in Point of Care Diagnostics and with audits.
Technical and scientific knowledge is required to understand the products and to review scientific issues and submission documents, labelling claims and clinical data. Experience with Point of Care instrument and Assay manufacturing and/or research and development strongly preferred.
High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
Excellent communications and presentation skills.
Ability to lead, influence, create and work within cross-functional, cross geography (including remote) team environments.
Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude, ability to adapt to changing regulatory and business environment and a sense of urgency to get things done.
Strong written and verbal communication skills; must be articulate and able to communicate effectively with corporate officers, DVPs, directors, managers, and employees across the organization.
Very strong attention to detail.
Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.
Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment
Required skills to have for the success of this role
Master of Science degree required, advanced degree preferred.
15+ years of medical device, including Point of Care Diagnostics.
10+ years leadership experience required.
Experience in strategic planning and collaboration with executive and key operational groups.
Progressive & proven record of leadership in managing regulatory organizations with global responsibility and establishing long term strategic growth initiatives.
Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
Extensive experience in cGMP and other Regulatory compliance requirements. Experienced in regulatory filings for US (510(k), IDE and PMA), EU, China and other key countries/regions.
Experience with managing or supporting clinical studies is desired.
Proven track record of successful regulatory submissions and negotiations, including 510(k) and CLIA waiver applications.
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.
The pay range for this position is $224,616 - $308,847 U.S. dollars annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience, as well as where the work will be performed. The annual incentive target is 30% 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
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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 .
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As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
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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.
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