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Description
This is an exciting opportunity to be part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to laboratories, partners, and patients globally. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.
In the Companion Diagnostics Business (CDx), our team partners with leading pharmaceutical companies to develop, manufacture, and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.
As the Regulatory Companion Diagnostics Professional, you will ensure compliance to medical device and CDx IVD regulations globally. In conjunction with Enterprise Global Regulatory Affairs, the CDx Regulatory Affairs Department communicates with worldwide health authorities in the licensing of all products in development or currently marketed globally. The Regulatory Professional integrates broad business concepts and strategies into structured projects leading design and delivery of new products and solutions as a key technical contributor. The ability to tackle complex, high-impact project design problems is required.
Main Responsibilities
Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.
Compiles materials required in submissions, license renewal, and annual registrations and maintains updated information about national/regional/global regulatory requirements.
Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort, and identifies and mitigates areas of risk.
Reviews product labeling and marketing materials for accuracy and compliance with regulations.
Response to customers and/or authorities' requests/inquiries dealing with regulations and product compliance.
Represents the company in external bodies dealing with standards and/or product regulations at the national/regional/global level.
May assess requirements and identify strategies for the earliest possible approvals of clinical trials applications.
Determines and develops approaches to assignments.
Leads regulatory projects requiring coordination with other functions, third parties.
Solves a broad range of problems of varying scope and complexity.
Qualifications
Bachelor’s or Master’s Degree or equivalent
At least 8+ years relevant experience for entry to this level.
Possess proven experience in an advanced medical devices regulatory role.
Requires in-depth knowledge and experience in the job and the ability to work independently.
Apart from these more technical skills, we are also looking for:
Excellent written and verbal communication skills, the ability to coordinate and prioritize efficiently.
Strong attention to detail and processes, ensuring compliance with Agilent's Quality standards, ability to handle customer expectations and balance customer requirements with business needs.
Experience with clinical trials will be a highly preferred skill.
#LI-PK1
What we offer:
The full-time, permanent position, based anywhere in the US or in Europe, is available as soon as possible. The role won’t be head-office based but working remotely.
We will make sure you get all the training and development opportunities you need to become the best in your field.
Agilent offers core global benefits to all staff - but in addition to these, the business offers Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Employee Assistance Program, Holiday, Company activities.
The US pay range for this full-time position is $ 114, - $210, /yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Additional details are available at: .
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email or contact +1-262-754-5030.For more information about equal employment opportunity protections, please visit
Option to Work Remote
Yes
Travel Required
Occasional
Shift
Day
Duration
No End Date
Job Function
Quality/Regulatory
Great News! We've discovered an exciting live job opportunity for a Sr. Regulatory Professional, CDx position in Copenhagen. This job is currently open for hiring/recruiting by Agilent, exclusively for you at Denmark Jobs Expertini. Feel free to download the job details here.
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The work culture at Agilent must adhere to the Ethics of Work Culture as described in the Ethical framework of the UN Charter. You can gain more insights into their local workplace environment by exploring their jobs Agilent and also by visiting their official website through Google.
The World Cities Report 2020 sheds light on the intrinsic value of sustainable urbanization in Denmark, particularly within Copenhagen. It explores this value from economic, social, and environmental angles, encompassing the intangible aspects that contribute to Copenhagen's distinct character. Moreover, the report delves into the role of innovation and technology, the responsibilities of local governments, targeted investments, and the effective implementation of the New Urban Agenda in promoting sustainable urbanization globally. For a deeper dive into population growth trends and diversity in Copenhagen, additional details can be found on Copenhagen Wikipedia.
Yes, we found live job(s) for Agilent in Copenhagen.
Sr. Regulatory Professional, CDx jobs are available in Denmark.
Exploring the cost of living in Copenhagen. At Expertini.Com for Copenhagen , we gauge it based on the percentage of earnings to living costs, typically ranging from 33% to 65% of your monthly income. This analysis empowers you to make informed decisions about your financial planning and lifestyle. Additionally, we recommend consulting with locals before making any moves to a new town.
The average salary range for Sr. Regulatory Professional, CDx in Copenhagen varies, but the standard pay scale is rated "Standard" in Copenhagen. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively.
To apply for a job at Agilent follow the application process following the "Apply Now" button at Denmark Jobs Expertini and also you can visit Agilent official career page and follow their application process.
Key qualifications for Sr. Regulatory Professional, CDx typically include a list of qualifications and expertise as outlined in Bureau of Labor. Be sure to check the specific job listing for detailed requirements and qualifications.
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Benefits for Sr. Regulatory Professional, CDx positions may include a list of benefits. These can vary from company to company, so it's important to review the specific job listing for details on benefits offered by the employer.
Not all jobs have remote job opportunities available. However, nowadays, many companies offer remote work options. You can find remote job listings for Sr. Regulatory Professional, CDx on Denmark Jobs Expertini.
To improve your chances of getting hired for Sr. Regulatory Professional, CDx, consider improving your skills. Also, make sure to check your Resume/CV Score with our free Resume Scoring Tool. Additionally, it is worth noting that Denmark Jobs Expertini has an in-built Ai Resume Scoring tool that will give you the matching score for each job based on your Resume/CV once it is uploaded. This can also help you align your Resume/CV according to the job requirements and enhance your skills if you fall short of them.
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