-
Specialist Regulatory Affairs
3 weeks ago
DivIHN Integration Inc North Chicago, 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 Associate
5 days ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 17 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
-
Regulatory Affairs Associate
3 days ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 15 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
-
Regulatory Affairs Associate
3 days ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 27 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
-
Regulatory Affairs Associate
4 days ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 16 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
-
Regulatory Affairs Associate
3 hours ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 12 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
-
Regulatory Affairs Associate
2 days ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 14 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
-
Regulatory Affairs Associate
5 days ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 18 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
-
Specialist Regulatory Affairs
3 weeks ago
DivIHN Integration North Chicago, 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 Associate
2 weeks 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
3 weeks 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 ...
-
Specialist Regulatory Affairs
2 weeks ago
DivIHN Integration North Chicago, United StatesDivIHN Integration Inc North Chicago, IL (Onsite) Full-TimeDivIHN (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 f ...
-
Regulatory Affairs Specialist
1 week ago
Onward Technologies Inc. Waukegan, United StatesTitle: Regulatory Affairs Specialist · Location: Waukegan, IL · Position Summary: · A Regulatory Affairs Specialist who can handle Regulatory requirements related to EUMDR for a Software as a Medical Device (SaMD). · Primary Duties:Perform gap analysis to understand the currents ...
-
Regulatory Affairs Specialist
1 week ago
Katalyst HealthCares & Life Sciences North Chicago, United StatesResponsibilities: Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. · Creates, reviews, and approves engineering changes. · Acts as core team member providing review and analys ...
-
Regulatory Affairs Specialist
3 weeks 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, ...
-
Specialist Regulatory Affairs
3 weeks ago
DivIHN Integration Green Oaks, 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
3 weeks 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
4 weeks 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
2 weeks 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 possibili ...
-
Regulatory Affair Specialist
4 days ago
Collabera Lake Forest, United StatesHome · Search Jobs · Job Description · Regulatory Affair Specialist · Contract: Lake Forest, Illinois, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 6 days, 3 hours left · Apply · Job Description: · RESPONSIBILITIES:Responsible for technical writing ...
Specialist Regulatory Affairs - North Chicago, United States - DivIHN Integration
Description
DivIHN Integration IncNorth Chicago, IL (Onsite)
Full-Time
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 atDivIHN (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 atto 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.
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.
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.
Regulatory, FDA, Randamp;amp;DRecommended Skills
Consumer Packaged Goods
Creativity
Decision Making
Filing
Labeling
Medical Material
Help us improve CareerBuilder by providing feedback about this job:
Job ID:
DIV
For yourprivacy and protection , when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilderTerms and Conditions for use of our website.
To use our website, you must agree with theTerms and Conditions and both meet and comply with their provisions.#J-18808-Ljbffr