Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
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.
This role combines knowledge of scientific, regulatory, and business issues to ensure that products are developed, manufactured, and distributed in compliance with global regulatory requirements. Under the direction of Regulatory Affairs Management, the Senior Regulatory Affairs Specialist acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and provides critical regulatory support for new product development. This is an on-site role in the Austin, Texas or Shoreview, Minnesota office with less than 20% travel requirements. This role won't support Visa sponsorship or Visa transfer.Key Responsibilities:
- Collaboratively interface with a variety of levels on significant matters, often requiring coordination across organizational units.
- Outline submission and clearance requirements in assigned geographies.
- Develop sound regulatory strategies in alignment with business priorities and update strategies based upon regulatory changes.
- Effectively collaborate with product development, quality, and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents).
- Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
- Compile, prepare, review, and submit high-quality regulatory submissions to authorities on time in US, EU, and Canada; support international regulatory team with submissions to other geographies as required.
- Interact and negotiate directly with regulatory authorities during development and review processes to ensure clearance/approvals.
- Effectively communicate internally with cross-functional teams and externally with regulatory agencies.
- Evaluate proposed design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance with regulatory requirements.
- Prepare and maintain annual licenses, registrations/listings for assigned geographies in a timely manner.
- Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
- Provide regulatory input for product recalls and recall communications.
- Support quality system and technical file/design dossier audits.
- Maintain regulatory files and tracking databases as required.
- Evaluate import/export requirements.
- Identify emerging issues and provide guidance to functional groups.
- Exercise good and ethical judgment within policy and regulations.
- Perform multiple tasks concurrently with accuracy.
- Provide guidance to functional groups in the development of relevant data for regulatory submissions.
- Support internal and external audits
Regulatory Role Specific:
- 5+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices.
- Must have 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.
- Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues.
- Ability to manage details effectively while contributing to broader regulatory strategies.
- Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993.
- Background in interventional oncology products, electromechanical devices and software in medical devices (SiMD/SaMD) is strongly preferred.
Educational background:
- Bachelor’s degree Engineering/ Life Sciences (advanced degree preferred)
- RAC certification (U.S. or EU) is a plus
Other qualifications:
- Ability to work collaboratively and/ independently in a fast-paced environment while managing multiple priorities.
- Clear and effective verbal and written communication skills with diverse audiences and personnel.
- Highly organized with ability to manage multiple projects/tasks simultaneously and effectively prioritize.
- Proficiency in MS Word, Excel, Adobe, and PowerPoint.
- Must be able to travel as needed
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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:
$93,680 - $128,810Factors 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.
Equal Employment Opportunity Statement: 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.
EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here.
Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.
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 here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [email protected]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.
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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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