-
Regulatory Affairs Associate
Found in: Appcast Linkedin GBL C2 - 9 hours ago
Planet Pharma North Chicago, United StatesAccountability / Scope: · As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. · Individual shall develop partnership with other regulatory ...
-
Regulatory Affairs Associate
Found in: Lensa US 4 C2 - 6 days ago
Planet Pharma North Chicago, United StatesAccountability / Scope: · As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. · Individual shall develop partnership with other regulato ...
-
Regulatory Affairs Specialist
Found in: Appcast US C2 - 1 day ago
DivIHN Integration Lake Bluff, United StatesDivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, ...
-
Regulatory Affairs Associate
Found in: Appcast Linkedin GBL C2 - 1 day ago
GForce Life Sciences Lake Forest, United StatesRegulatory Affairs Associate – Abbott Park, IL · Must be able to work on a W2 · Job Summary: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and ...
-
Regulatory Affairs Specialist
Found in: Appcast Linkedin GBL C2 - 1 day ago
GForce Life Sciences Lake Forest, United StatesRegulatory Affairs Specialist – Onsite in Lake Forest, IL · Must be able to work W2 · Summary · Our client, a Fortune-500 Medical Device Company, has requested that we find them a regulatory affairs specialist to provide support and ensure efficient and compliant business proces ...
-
Regulatory Affairs Specialist
Found in: Appcast US C2 - 4 days ago
GForce Life Sciences Lake Forest, United StatesThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. · TERM & START · 1-year contract starting 6/10/24 with possibil ...
-
Regulatory Affairs Associate/IVDR
Found in: Appcast US C2 - 7 hours ago
Intellectt Inc North Chicago, United StatesRole: Regulatory Affairs Associate · Location: Lake Forest, IL · Duration: 12 Months · Job description · candidate will be responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR)... Provides regulatory support for diagn ...
-
Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 2 days ago
GForce Life Sciences Lake Forest, United StatesThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. · TERM & START · 1-year contract starting 6/10/24 with possibi ...
-
Regulatory Affairs Specialist
Found in: Appcast US C2 - 5 days ago
Intellectt Inc Lake Forest, United StatesThe position of Regulatory Affairs Specialist II is within our Infectious Disease business · unit. In this role you will prepare documentation for EU Technical Files and international · product registrations. · This job description will be reviewed periodically and is subject to ...
-
Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 6 days ago
GForce Life Sciences Lake Forest, United StatesRegulatory Affairs Specialist Onsite in Lake Forest, IL · Must be able to work W2 · Summary · Our client, a Fortune-500 Medical Device Company, has requested that we find them a regulatory affairs specialist to provide support and ensure efficient and compliant business proce ...
-
Regulatory Affairs Associate
Found in: Lensa US 4 C2 - 2 days ago
Spectraforce Technologies Lake Forest, United StatesJob Title: Regulatory Affairs Associate · Location: Lake Forest, IL (Open for Remote) · Duration: 12 Months · Shift: 8 am - 5 pm · Duties:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). · Provides regulatory sup ...
-
Regulatory Affairs Associate
Found in: Appcast US C2 - 2 days ago
DivIHN Integration Inc Lake Forest, United StatesDivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 200 ...
-
Manager, Regulatory Affairs
Found in: Lensa US 4 C2 - 5 days ago
ICU Medical Lake Forest, United StatesJob Title Manager, Regulatory Affairs – Electromechanical Devices FLSA Status Exempt Work Arrangement Hybrid Position Summary The Manager, Regulatory Affairs is a working Manager who assists in development and execution of Global Regulatory Strategies and Plans to assure that new ...
-
Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 3 days ago
INTELLECTT INC Lake Forest, United StatesThe position of Regulatory Affairs Specialist II is within our Infectious Disease business · unit. In this role you will prepare documentation for EU Technical Files and international · product registrations. · This job description will be reviewed periodically and is subject ...
-
Regulatory Affairs Specialist
Found in: ZipRecruiter Priority US C2 - 2 days ago
Talentrupt RPO Lake Forest, United StatesJob Description · Job Description Job Title - Regulatory Affairs Specialist · Location – Lake Forest, IL 60045(Onsite Role) · Duration – 12+ months of contract role · Pay rate $33/hr on w2 · The position of Regulatory Affairs Specialist II is within our Infectious Disease busine ...
-
Regulatory Affairs Associate
Found in: ZipRecruiter Priority US C2 - 2 days ago
Collabera Lake Forest, United StatesJob Description · Job Description · Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS packages from draft to final closure. · Prepares metrics associated with the process for Executive Management Review (EMR ...
-
Regulatory Affairs Specialist II
Found in: Appcast US C2 - 1 day ago
DivIHN Integration Inc Lake Forest, United StatesDivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 200 ...
-
Regulatory Affairs Specialist II
Found in: ZipRecruiter Test10P US C2 - 2 days ago
DivIHN Integration Inc Lake Forest, United StatesJob Description · Job DescriptionFor further inquiries regarding the following opportunity, please contact one of our Talent SpecialistRashi | Title: Regulatory Affairs Specialist II - 3 Openings · Location: Lake Forest, IL · Duration: 12 MonthsDescription · The position of Regul ...
-
Regulatory Affairs Associate Jr
Found in: Appcast US C2 - 7 hours ago
DivIHN Integration Inc Lake Forest, United StatesDivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 200 ...
-
Remote Regulatory Affairs Associate
Found in: ZipRecruiter Priority US C2 - 2 days ago
Select Source International Lake Forest, United StatesJob Description · Job Description Client: Medical Device · Job Title: Regulatory Affairs Associate · Location: Remote · Duration: 12+ Month · Duties: candidate will be responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IV ...
Specialist Regulatory Affairs - North Chicago, United States - DivIHN Integration Inc
Description
DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at
to learn more and view our open positions.Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Meghna at
Rashi at
Title: Specialist Regulatory Affairs
Duration: 7 Months
Location: Abbott Park, IL/ Columbu, OH
Description
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.
Accountability / Scope:
As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global.
Individual shall develop partnership with other regulatory functions, affiliates and other stakeholder to define plan and strategy for submissions and any deficiencies and develop approach to solutions.
Individual shall be good with excel and numbers, so that they can help analyze submission numbers and various metrics.
RESPONSIBILITIES
Major Responsibilities:
Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF and FUF, Drug for EURI/ MENAP/ global. Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc
Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes
Partnership with affiliates to support regulatory agency interactions to expedite approval of pending registration.
Participates/ Awareness on project plans, regulatory submission strategy, any risks management.
Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Partner with other regulatory functions for smooth project transition and launch.
Support review of change controls to determine the level of change and consequent submission requirements
Support pulling reports, metrics related to submissions and approvals.
Offers country specific regulatory support
Stakeholders:
Direct interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project Management, Strategic Area and other stakeholders such as Project managers, Manufacturing Plants, affiliates, RandD, Technical center and Product Developers.
Skills/Experience Requirements
Requirements include:
Prior experience (2-3yrs) and Bachelor's degree in nutrition/science related field.
Good understanding and working experience in different regulatory environment in multiple countries.
Experience in registration filing process of new nutrition products preferred.
Knowledge and understanding of formulation and scientific aspects of nutritional products.
Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.
3-5 years of regulatory exp, nutrition, healthcare, pharma exp or background, FMCG preferred, submission exp, system exp, Regulatory policies, operations exp, industry exp.
Flexible for any regulatory exp but preferred is operations regulatory, building doc, building product docs.
Day-to-day duties
Will work with a team, preparing docs, initially, they will be trained, and pull documents and reports from the system, documentation, it is an execution role, mostly depending on documentation, system experience, and regulations.
Adaptable in cultural and political diversity.
Capacity to learn and challenge status quo.
Team player
Self-motivated.
Education
Lowest level BS with some years of experience
Highest level- MS or PhD with 2 years experience
Interview: 1 round, virtual.
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
