Regulatory Affairs Associate
Hire Talent
Regulatory Affairs Specialist
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Associate in Lake Forest, IL vacancy
- ...of planned submissions and approvals in a region to: Supports regulatory information management activities in the region focusing on... ...Correspondence/responses from agency are imported into Cosmos in association with relevant activity Response structures linked to relevant...SuggestedLocal area
Planet Pharma Group
North Chicago, IL4 days ago - ...Responsibilities Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU. Create... ...initiatives. Requirements Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline. Experience...Suggested
Katalyst CRO
North Chicago, IL11 hours ago - ...of planned submissions and approvals in a region to: Supports regulatory information management activities in the region focusing on... ...Correspondence/responses from agency are imported into Cosmos in association with relevant activity Response structures linked to relevant...SuggestedFull timeLocal area
Synectics
North Chicago, IL4 days ago $40 - $50 per hour
...coordinate activities with all functional departments in support of regulatory filings. location: North Chicago, Illinois job type: Contract... ...pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3) #LI-AM1 skills: Project...SuggestedHourly payContract workTemporary workWork experience placementShift workRandstad
North Chicago, IL5 days ago- ...Senior Pharmaceutical Recruiter – Unicon Pharma Inc Regulatory Affairs Specialist Provide regulatory support for U.S. and global medical device... ...in medical devices (RAC preferred). Seniority level: Associate Employment type: Contract Job function: Analyst Industries:...SuggestedContract work
Unicon Pharma
Lake Forest, IL1 day ago - ...Regulatory Affairs Associate I Are you a recent life sciences graduate looking to launch your career with a Top-Tier Global Pharma Leader? This hybrid Regulatory Affairs Associate I role in North Chicago, IL, offers an incredible opportunity to gain hands-on experience...Contract work
Randstad
Great Lakes, IL3 days ago - ...Job Title: Regulatory Affairs Associate. Location: Lake Forest, IL Duration: 12 Months Pay Rate: $33-$35 on W2 per hour. Position Summary Provides regulatory support and expertise associated with global and US electronic publishing and submission of...Hourly pay
eTeam
Lake Forest, IL1 day ago - Planet Pharma in North Chicago, Illinois, is looking for individuals to support regulatory information management activities. The role involves using knowledge of regulatory submissions to ensure accurate tracking and reporting across regions. We welcome fresh graduates...
- ...Senior Pharmaceutical Recruiter. The ideal candidate will provide regulatory support for both U.S. and global medical device submissions,... ...'s degree and at least 2 years of experience in Regulatory Affairs within the medical device field are essential. #J-18808-Ljbffr...
Unicon Pharma
Lake Forest, IL2 days ago - ...Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software...
Katalyst Healthcares and Life Sciences
North Chicago, IL4 days ago - BioSpace in North Chicago is looking for a candidate to ensure GxP compliance with AbbVie policies and global regulations. The role requires managing compliance initiatives and working effectively within team environments. A Bachelor’s degree in a scientific field is required...
$28 per hour
...Are you a recent life sciences graduate looking to launch your career with a Top-Tier Global Pharma Leader? This hybrid Regulatory Affairs Associate I role in North Chicago, IL, offers an incredible opportunity to gain hands-on experience in regulatory information management...Hourly payContract workTemporary workWork experience placement3 days per week- Bank of America is seeking a Financial Solutions Advisor Stage I in Lake Forest, Illinois, focused on enhancing clients' financial lives through tailored solutions. The role involves obtaining necessary licenses and engaging in client-facing activities within a financial...
- An established industry player is seeking a detail-oriented logistics coordinator to manage import/export processes. This role involves supporting internal customers with shipment coordination, ensuring compliance with U.S. regulations, and maintaining accurate documentation...
- The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross‑functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content...Temporary work
- BioSpace is seeking an Associate for Regulatory Affairs in North Chicago, Illinois. The role involves managing submission projects, ensuring timely and quality deliveries of submissions, and working with cross-functional teams. A Bachelor's degree and 2+ years in the pharmaceutical...
$97.5k - $139.75k
Position Summary Provides regulatory support and expertise associated with global and US registration of medical deviceproducts, including in-depth analysis... ...agency review. Represents Global Regulatory Affairs at research and development meetings and presents agreed...Work at officeLocal area- BioSpace is looking for a qualified individual to ensure GxP compliance with AbbVie policies and global regulatory requirements. The role involves proactive evaluation of compliance needs and managing process improvements to enhance efficiency. Candidates should possess...
- Allergan is hiring an Associate in Regulatory Affairs Submission Management in North Chicago, IL. This role involves managing submission projects and ensuring compliance with regulatory standards. Candidates should have a Bachelor’s Degree and at least 2 years of relevant...
- Planet Pharma Group is seeking a Regulatory Information Management professional in North Chicago, Illinois. The role involves supporting regulatory information management activities and ensuring accuracy in submissions and approvals. Qualified candidates should possess...
- ...cost efficiencies. Act as a trusted source for trade compliance insights by proactively tracking, interpreting, and communicating regulatory and legislative updates to GTC stakeholders—ensuring the organization stays ahead of potential impacts with timely and actionable...Temporary workLocal areaWorldwide
AbbVie
North Chicago, IL2 days ago - Synectics Inc. in North Chicago is looking for a professional to support regulatory information management activities. Responsibilities include managing product registrations and ensuring accurate tracking of approvals and submissions in central systems. The ideal candidate...
- Katalyst CRO is seeking a professional for a Regulatory Affairs position located in North Chicago. Responsibilities include supporting regional Regulatory Information Management activities, maintaining regulatory records, and ensuring compliance across markets. The ideal...
$20 - $24 per hour
Pay : $20.00 - $24.00/HR based on experience! Duration : 1-year contract (potential to extend/convert based on performance/budget) Location : 100% onsite; M-F 8:30 AM - 5:00 PM Responsible for: Support internal customers in coordinating the inbound and outbound shipment...Contract work$40 - $45 per hour
...Position Summary The Regulatory Affairs Specialist supports the Regulatory Affairs team by assisting with the review, maintenance, and communication of regulatory information for company products. This role helps ensure product compliance across applicable markets and...Hourly payWork at officeLocal areaCPS
Northbrook, IL1 day ago$76.96k - $125.84k
Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year...Hourly payFull timePart timeWork at officeFlexible hours- ...Title: Regulatory Affairs Specialist Location: Mundelein, IL Duration: 3 to 6 Months Pay range: $25/hr to $30/hr Day-to-Day: Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine...Temporary work
Collabera
Mundelein, IL4 days ago - ...distributor of shipping materials is seeking an International Trade Compliance Specialist in Waukegan, IL. This role involves tackling regulatory hurdles and managing trade compliance programs while supporting the global economy. Candidates should hold a Bachelor’s degree...
Carlsbad Tech
Waukegan, IL1 day ago - ...experience in compliance, risk, legal, or regulated environments ~ Strong analytical skills and the ability to distill complex regulatory material ~ Proven ability to manage multiple priorities independently ~ Excellent written and verbal communication skills ~...Full timeTemporary workWork at officeLocal areaRemote workFlexible hours
LOGS Legal Group
Bannockburn, IL2 days ago $82k - $93k
...of internal and/or external audits for Consumer Compliance related issues to ensure timely and accurate responses and remediation Regulatory developments and ensuring timely implementation of new or revised requirements Compliance reports for senior management and...First Bank Chicago
Northbrook, IL2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Associate. Be the first to apply!
Related searches
- regulatory contract Lake Forest, IL
- regulatory law Lake Forest, IL
- regulatory engineer Lake Forest, IL
- regulatory Lake Forest, IL
- vendor compliance Lake Forest, IL
- regulatory compliance Lake Forest, IL
- regulatory affairs Lake Forest, IL
- compliance team leader Lake Forest, IL
- regulatory affairs assistant Lake Forest, IL
- pharmaceutical regulatory affairs Lake Forest, IL