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Regulatory Affairs Strategist
As a Cerner Regulatory Affairs Strategist, you will contribute to the regulatory submission process and aid in authoring of submissions for US and global markets (510(k) and technical file(s)). You will also assess product and manufacturing changes for compliance with applicable standards and regulations and prepare submissions and reports as required. You will provide regulatory input for product design and development, including review of specifications, protocols and reports, change control, product complaints, and product failure analysis. In addition, you will provide regulatory input to device development teams for compliance with ISO Standards and medical device regulations and will participate in internal and external audits. We are glad you are considering joining our team and making your impact on health and care.
This position offers a Hybrid or Remote working environment. Meaning if you live within a metro area of a Cerner office, you will split working time between a Cerner office and remote. If you are not within a metro area of a Cerner office, you can live and work in your current geographical location and work primarily remote. #LI-Hybrid #Remote
- At least 6 years of total combined higher education and related work experience, including:
- 1 years of compliance, regulatory affairs and/or quality management work experience
- 5 years of higher education and/or additional work experience directly related to the duties of the job
- Bachelor’s degree
- Willing to work additional or irregular hours as needed and allowed by local regulations
- Work in accordance with corporate and organizational security policies and procedures, understand personal role in safeguarding corporate and client assets, and take appropriate action to prevent and report any compromises of security within scope of position
- Perform other responsibilities as assigned
Applicants for U.S. based positions with Cerner Corporation must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position.
Some Cerner positions may be obligated to comply with client-facing requirements and occupational health requests, including but not limited to, an immunization set, covid-19 vaccination, an annual flu shot, an annual TB screen, an updated background check, and/or an updated drug screen.
Cerner is a place where people are encouraged to innovate with confidence and focus on what is important – people’s health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.
Cerner’s policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Cerner is proud to be a drug-free workplace.
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Job posted: 2022-07-10