Regulatory Affairs Specialist jobs in Delaware
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
Regulatory Affairs Specialist
- Siemens Healthineers
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Newark, DE
FULL_TIME
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Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Regulatory Affairs Specialist to support international registrations.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Regulatory Affairs Specialist, you will be responsible for:- Preparing, submitting, and managing regulatory applications required for product market approvals in global market.
- Preparing, submitting, and managing Technical Files in compliance with the requirements of the local regulatory and the Quality Management System.
- Prepare, submit, and manage FDA PMA Annual Reports, FDA PMA 30-day notices or other supplements, 510(k) notes to file, 510(k) submissions, Notified body Annex II notifications, notification in line with IVDR requirements, other notifications other notifications.
- Acting as a Regulatory Affairs subject matter expert on new product introduction and design control teams.
- Participating in internal and external quality system and design dossier audits
- Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance.
- Knowledge of IVD products and applicable regulations for such products
- You have very good presentation skills, and you show team orientation and communication skills.
- Ensure cross-functional collaboration and cooperation.
- Excellent attention to details.
- Able to multi-task and work effectively in a dynamic environment.
- Bachelor’s degree in scientific discipline
- Minimum of 5 years of experience in IVDs or Medical Device.
- Skilled in Outlook, SharePoint, Adobe Acrobat and Microsoft Office applications, including Excel
- Intercultural sensitivity
- Strong attention to detail and excellent organizational skills
This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.
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.
Beware of Job Scams
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site.
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.
“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
Equal Employment Opportunity Statement
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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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.
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California residents have the right to receive additional notices about their personal information. To learn more, click here. - 6 Days Ago
Regulatory Affairs Specialist
- NemoursCareerSite
-
Wilmington, DE
FULL_TIME
- Nemours is seeking a Regulatory Affairs Specialist to join our team in Wilmington, DE. Under the direction of the Manager of Regulatory & Accreditation Affairs, the Regulatory Affairs Specialist is re...
- 1 Month Ago
Regulatory Affairs Specialist
- Hologic Careers
-
Newark, DE
FULL_TIME
- Hologic is seeking a Regulatory Affairs Specialist to join our expanding Innovation Center located in Newark, DE. What to Expect: The Regulatory Affairs Specialist is expected to perform the coordinat...
- 2 Months Ago
Regulatory Affairs Professional 2
- APN Software Services, Inc.
-
Newark, DE
FULL_TIME
- Client: SiemensJob title: Regulatory Affairs Professional 2 / IVDR International registrationLocation: Newark, DE 19702Duration: 12 MonthsDescriptionAnalyzes the requirements and prepares product rela...
- 4 Days Ago
Regulatory Affairs Manager
- Centrica Services Ltd (UK)
-
Hamburg, DE
FULL_TIME
- We are Centrica! We’re so much more than an energy company. We’re a family of brands revolutionising a cleaner, greener future. Working here is #MoreThanACareer - we’re powered by purpose. Together we...
- 19 Days Ago
Regulatory Specialist
- State of Delaware - DOL/Administration
-
Dover, DE
FULL_TIME
- Summary StatementDelaware has a new mandate to give workers paid leave to bond with a new child or to tend to their own or a loved one’s illness or injury and this position will support that effort. T...
- Just Posted
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/12/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory aff...
- 6/12/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Experis
-
Maplewood, MN
- Our client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
- Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
- Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
- 6/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
-
- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 6/8/2024 12:00:00 AM
About Delaware
Delaware is 96 miles (154 km) long and ranges from 9 miles (14 km) to 35 miles (56 km) across, totaling 1,954 square miles (5,060 km2), making it the second-smallest state in the United States after Rhode Island. Delaware is bounded to the north by Pennsylvania; to the east by the Delaware River, Delaware Bay, New Jersey and the Atlantic Ocean; and to the west and south by Maryland. Small portions of Delaware are also situated on the eastern side of the Delaware River sharing land boundaries with New Jersey. The state of Delaware, together with the Eastern Shore counties of Maryland and two co...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$77,491 to $103,846
Most Popular Cities in Delaware for Regulatory Affairs Specialist Jobs
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Petaluma, CA
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019