Current jobs related to Regulatory Affairs Coordinator - La Vista - Streck, LLC
-
Regulatory Affairs Coordinator
1 month ago
La Vista, United States Streck Full timeDescription Streck Provides A challenging, safe and rewarding work environment. No night or weekend shifts. Excellent work life balance. Affordable, high-quality apartments for employees. Market competitive pay. Comprehensive and inclusive benefits. Great team environment. On and off campus career development opportunities. Summary of Responsibilities This...
-
Public Affairs Communications Specialist
4 weeks ago
Flogny-la-Chapelle, Bourgogne-Franche-Comté, United States Crew Training International Full timeAbout Crew Training InternationalCrew Training International is a leading provider of training and educational programs for individuals and organizations in the aviation industry. We are committed to delivering high-quality training solutions that meet the needs of our clients and help them achieve their goals.We are seeking a highly skilled and experienced...
-
State of Illinois Office Coordinator
2 weeks ago
La Salle, Illinois, United States State of Illinois Full timeThe State of Illinois is seeking a highly skilled Office Coordinator to join our team. As an Office Coordinator, you will be responsible for providing administrative support to the Department of Veterans' Affairs.About the RoleThis is a salaried position with an anticipated starting salary of $3971/month. The successful candidate will have experience in...
-
Office Coordinator
2 weeks ago
La Salle, Illinois, United States State of Illinois Full timeThe State of Illinois is seeking a detail-oriented and organized Office Coordinator to join our team. In this role, you will provide administrative support to the Department of Veterans' Affairs and contribute to the success of our organization.About the OpportunityThis is a salaried position with an estimated annual salary of $47,532-$62,716. The successful...
-
Program Coordinator
7 days ago
Vista, California, United States SOL TRANSPORTATION INC Full timeSol Transportation Inc. is seeking a Program Coordinator to assist in managing daily operations, ensuring compliance with policies and regulatory standards, and promoting a positive work environment.Job Summary:This role involves overseeing staff, monitoring program performance, and implementing effective solutions to improve efficiency and service...
-
Disaster Response Coordinator
7 days ago
La Plata, Maryland, United States University of Maryland Medical System Full timeAbout UsThe University of Maryland Charles Regional Medical Center is a top-ranked healthcare institution that values teamwork and collaboration. Our diverse group of professionals represents our strength, and we strive to serve our patients and community with unwavering commitment.Job SummaryWe are seeking an experienced professional to coordinate emergency...
-
Outpatient Access Coordinator
4 days ago
La Grange, Illinois, United States AdventHealth Full timeAbout the RoleThe Outpatient Access Coordinator will play a vital role in coordinating patient access services for our AdventHealth La Grange facility. This position requires strong organizational and communication skills to ensure timely and accurate registration of patients.Key ResponsibilitiesCoordinate patient registration and scheduling processesVerify...
-
Faith Services Coordinator
4 days ago
La Cabanasse, Occitanie, United States Ladgov Corporation Full timeJob Summary:We are seeking a Faith Services Coordinator to join our team at Ladgov Corporation. As a Faith Services Coordinator, you will be responsible for providing Muslim Clergy Services to the Military Corrections Command at the United States Disciplinary Barracks and the Joint Regional Correctional Facility.Key Responsibilities:Conduct weekly Muslim...
-
Chula Vista, California, United States MAAC (Metropolitan Area Advisory Committee) Full timeJob OverviewThe Senior Project Manager or Project Manager is responsible for leading the development of affordable housing projects from initiation to completion. The ideal candidate will have a strong background in project management, real estate development, and finance.**Estimated Salary: $85,000 - $130,000 per year**Key Responsibilities:Evaluate...
-
Healthcare Support Coordinator
5 days ago
La Puente, California, United States PIH Health Full timeAbout This Role:This position plays a crucial role in facilitating communication between patients, healthcare providers, and insurance companies. As a Medical Assistant, you will be responsible for managing patient information, coordinating treatment plans, and ensuring compliance with regulatory requirements.Key Responsibilities:- Coordinate outside...
-
Youth Residential Program Coordinator
2 weeks ago
Vista, California, United States New Haven Youth Full timeAbout the RoleThis is a challenging yet rewarding role that requires strong leadership skills, attention to detail, and a passion for working with young people. As a Residential Facility Manager, you will be responsible for ensuring the smooth operation of our overnight facility, including supervising staff, maintaining records, and adhering to regulatory...
-
La Vista, Nebraska, United States Inner Circle Autism Network Full timeUnlock the Potential of Children with AutismWe are seeking a highly skilled Board Certified Behavior Analyst (BCBA) to join our multidisciplinary team at Inner Circle Autism Network. As a BCBA, you will play a critical role in designing and overseeing individualized programs for children diagnosed with autism spectrum disorders.Salary: $105,000 and up plus...
-
HEDIS Program Coordinator
2 weeks ago
Chula Vista, California, United States Community Health Group Full timeAbout the RoleOversee the accuracy and timely submission of all HEDIS data to software vendors, upholding data integrity and adhering to reporting timelines.Lead compliance initiatives, identifying, planning, communicating, and evaluating necessary actions to meet evolving regulatory, accreditation, and industry standards.Conduct timely analysis of...
-
Community Living Coordinator
5 days ago
La Junta, Colorado, United States Bluestem Village Full timeJob Title: Community Living CoordinatorEstimated Salary: $40,000 - $50,000 per yearAbout Bluestem VillageWe are a community-focused organization dedicated to providing exceptional long-term care services. Our team is committed to creating a warm and welcoming environment that promotes independence, dignity, and well-being for our residents.Job...
-
Supply Chain Coordinator Lead
1 week ago
La Crosse, Wisconsin, United States City Brewing Company Full timeWe are seeking an experienced Warehouse Coordinator to join our team at City Brewing Company. As a key member of our warehouse operations team, you will play a critical role in ensuring the smooth flow of goods and materials through our facilities. Your primary responsibilities will include assisting the shift supervisor with daily operations, managing...
-
Construction Project Coordinator
4 weeks ago
La Feria, Texas, United States Noble Texas Builders Full timeOverviewNoble Texas Builders is a dedicated team of construction professionals committed to delivering high-quality results. We prioritize job site safety and professionalism, offering advancement opportunities through in-house training.Job SummaryWe are seeking an experienced Construction Project Manager for our La Feria location to facilitate the smooth...
-
Affordable Housing Project Coordinator
4 days ago
Chula Vista, California, United States MAAC (Metropolitan Area Advisory Committee) Full timeAbout MAAC">Since 1965, MAAC has been maximizing self-sufficiency with families and individuals through high-quality programs and advocacy in our communities.We employ dedicated staff who provide life-changing services to thousands of individuals annually through programs in five core focus areas: Education, Economic Development, Health & Wellbeing, Housing,...
-
Operations Manager
7 days ago
Vista, California, United States SOL TRANSPORTATION INC Full timeWe are seeking a highly skilled and detail-oriented Operations Manager to oversee daily operations, manage staff, and ensure compliance with policies and regulatory standards. This role is key to ensuring efficient scheduling, quality service delivery, and a positive work environment.Key Responsibilities:Assist the Director of Operations with coordinating...
-
Intermodal Operations
2 days ago
La Porte, United States Green Mile Logistics Inc. Full timeJob Description: Intermodal Operations & Customer Service CoordinatorReports To: Terminal ManagerCollaborates With: Driver Manager, Operations Team, and CustomersPosition OverviewThe Intermodal Operations & Customer Service Coordinator is a dynamic role combining customer-facing responsibilities with operational dispatch duties. This position is pivotal in...
-
Intermodal Operations
2 weeks ago
La Porte, United States Green Mile Logistics Inc. Full timeJob Description: Intermodal Operations & Customer Service CoordinatorReports To: Terminal ManagerCollaborates With: Driver Manager, Operations Team, and CustomersPosition OverviewThe Intermodal Operations & Customer Service Coordinator is a dynamic role combining customer-facing responsibilities with operational dispatch duties. This position is pivotal in...
Regulatory Affairs Coordinator
2 months ago
Streck Provides
- A challenging, safe and rewarding work environment.
- No night or weekend shifts.
- Excellent work life balance.
- Affordable, high-quality apartments for employees.
- Market competitive pay.
- Comprehensive and inclusive benefits.
- Great team environment.
- On and off campus career development opportunities.
Summary of Responsibilities
This position will be responsible for supporting global and domestic regulatory compliance at Streck. The areas of responsibility include assistance with international and domestic regulatory submissions, coordination of risk management activities and design control process support. This position will also perform other duties assigned by the manager.
Essential Duties and Functions
- Serve as the corporate contact for International Registrations by gathering documentation, obtaining legalization/apostille information, and communicating with distributors, private label accounts, and other corporate partners regarding international registration.
- Provide corporate guidance on domestic and international Unique Device Identification (UDI) requirements.
- Provide assistance in product and manufacturing process changes for regulatory impact to international registrations requirements.
- Provide support data and rationale if necessary.
- Create, modify, and / or update finished product SDS as required.
- Identify and coordinate data collection requirements for regulatory submission, new products and / or changes to existing products. Complete associated statistical analyses and reports as required.
- Assist with Design Control project coordination and support as required.
- Serve as Regulatory review for printed materials as required.
- Assist in the completion and management of domestic and international IVD submissions/technical files. Participate in Underwriters Laboratories (UL) filings as required and act as a liaison when assigned.
- Review proposed permanent product, process, or manufacturing changes process for effect on regulatory requirements.
- Participate in Supplier and Internal Audit programs as assigned.
- Perform all other duties as assigned by management.
Position Requirements
- Bachelor‘s degree in a business or science-related discipline.
- Four years of experience participating in project management teams preferred.
- Four years of experience in the implementation of process improvement efforts.
- Four years of related experience in an FDA regulated manufacturing environment preferred.
Technical Competencies
- Sound knowledge of good manufacturing practices (GMP) and FDA regulations affecting medical devices (QSR).
- Understanding of ISO, EU and CMDR Quality System requirements and conditions.
- Ability and willingness to learn Domestic and International Product Registration requests (IVD).
- Strong PC skills and knowledge of word processing, spreadsheet, and database applications
- Experience in quality system auditing and change management preferred.
Work Environment/Travel Demands
The work environment is a climate-controlled biological/chemical laboratory. Occasional short durations to cold temperatures inside walk-in coolers. Ability to wear required laboratory clean room clothing (laboratory coats, hair bonnets, and beard covers (as applicable) and other safety/protective equipment (masks, gloves, and/or face shields for example) for up to two and a half hours consecutively. Travel demands for this position are estimated up to 0%. If travel is required, this travel may include customer visits, events/trade shows, and completion of presentations primarily throughout Domestic US or International regions. Employees must comply with all travel recommendations regarding ‘safe travel‘ according to company policies and guidelines, and all federal, state, local, and international orders.
Physical and Mental Demands
Light work exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or up to 5 pounds of force constantly to move objects. This also includes standing for up to two and a half hours consecutively, walking, pushing, pulling, lifting, reaching, stooping, fingering, and grasping. Expressing and receiving detailed information through written and oral communication. Also has an ability to make sound, appropriate, and prompt decisions within the guidelines of the role.
**The work environment characteristics and physical demands stated in their respective sections are representative of those necessary to perform the essential functions of the job. Reasonable accommodations will be reviewed and considered. If approved, accommodation may be made to enable individuals with disabilities to perform the essential functions of their assigned role.
The above statements are intended to describe the general nature of work being performed by people assigned to this classification.They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Visit www.streckcareers.comto learn more about Streck and apply for this opportunity.
Streck is an Equal Opportunity/Affirmative Action employer and forbids discrimination against any employee or applicant because of race, color, religion, gender (including pregnancy, gender stereotyping and caregiver status), sexual orientation, gender identity, transgender status, national origin, disability, genetic information, citizenship, marital status or status as a covered veteran in accordance with applicable federal, state and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor‘s legal duty to furnish information. 41 CFR 60-1.35(c)
