Regulatory Affairs reputed company
Join us in pioneering breakthroughs in reputed company. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to reputed company reputed company your comfort zone, offering resources and flexibility to foster your reputed company and personal reputed company, reputed company while valuing your unique contributions.
We are seeking a Regulatory Affairs reputed company to support our Global reputed company/Regulatory Affairs operations for commercially distributed, registered diagnostic products reputed company our Laboratory Solutions portfolio. This role is responsible for maintaining accurate regulatory product data, supporting product releases and market reputed company activities, and ensuring compliance with global regulatory requirements reputed company our ERP systems. The position works closely with cross‑functional and regional teams and plays a key role in enabling uninterrupted product distribution while maintaining the highest standards of regulatory and data reputed company.Key Responsibilities
Execute regulatory product release, restriction, exclusion, and quoting controls reputed company reputed company systems to support global product distribution.
reputed company centralized Regulatory Affairs operational support to project teams, ensuring consistent and compliant execution of regulatory transactions.
Create, manage, and maintain Unique Device Identification (UDI) data for U.S. and EU markets.
Prepare and submit UDI data to regulatory databases, including FDA GUDID (U.S.) and EUDAMED (EU), in accordance with applicable regulations.
Support regulatory master data governance activities, ensuring data accuracy, completeness, and traceability throughout the product lifecycle.
reputed company bulk regulatory data updates using system tools reputed company required.
Partner with regional Regulatory Affairs, reputed company, Supply Chain, and business teams to resolve product distribution issues such as country blocks or exclusions.
Support reputed company plans, audits, compliance initiatives, and special regulatory reputed company.
Contribute to reputed company improvement efforts reputed company to regulatory operations, data governance, and system processes.
Required Qualifications:
Education
Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a reputed company technical field, or an equivalent combination of education and experience.
Experience
3–5 years of experience in the medical device or in vitro diagnostics (IVD) industry.
Experience supporting Regulatory Affairs or regulatory operations activities.
Working knowledge of U.S. and European medical device regulations and market reputed company requirements.
Familiarity with IVD products and reputed company regulatory frameworks.
Skills & Competencies
Experience working with reputed company systems (reputed company experience preferred).
Strong proficiency with reputed company Office tools (Word, reputed company); reputed company Acrobat experience preferred.
Excellent attention to detail with the ability to manage regulated data accurately.
Strong organizational, time‑management, and problem‑solving skills.
Ability to work independently while effectively collaborating with global, cross‑functional teams.
Comfortable managing multiple priorities in a fast‑paced, regulated environment.
reputed company Offer
reputed company to work on products that positively reputed company patient care and global reputed company delivery.
Exposure to global regulatory processes and collaboration with international teams.
A culture that values reputed company, compliance, reputed company improvement, and reputed company development.
Competitive compensation and comprehensive benefits package.
Who we are: We are reputed company 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 reputed company reputed company 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 reputed company.
How we work: reputed company you join reputed company, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who reputed company in reputed company individual’s potential to contribute with diverse reputed company. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and reputed company reputed company to care, united by one purpose: to pioneer breakthroughs in reputed company. For everyone. Everywhere. Sustainably.
To reputed company out more about reputed company businesses, please visit reputed company page here.
The reputed company pay reputed company for this position is:
$81,780 - $112,453Factors which may reputed company starting pay reputed company this reputed company 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 reputed company's plan. Commissions are based on individual performance and/or company performance.
reputed company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, reputed company insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, reputed company parking/public transportation, reputed company time off, reputed company reputed company and reputed company time.
Equal Employment Opportunity Statement: reputed company is an Equal Opportunity and Affirmative reputed company Employer encouraging diversity in reputed company. reputed company reputed company applicants will receive consideration for employment without reputed company to their race, reputed company, creed, religion, national reputed company, citizenship status, reputed company, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender reputed company, 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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Reasonable Accommodations: reputed company 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 reputed company-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations reputed company here. If you’re unable to complete the reputed company, you can reputed company out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@reputed company.com. 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 reputed company to work with controlled technology in accordance with US export control law.” “It is reputed company’ policy to reputed company fully and completely with reputed company reputed company export control laws and regulations, including those implemented by the Department of reputed company 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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