- Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
- Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
- Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Assist in preparation and review of regulatory submission to authorities.
- Maintain annual licenses, registrations, listings and patent information.
- Assist compliance with product postmarketing approval requirements. Assist in the review of advertising and promotional items.
- Assess external communications relative to regulations. Review regulatory aspects of contracts.
- Assist with label development and review for compliance before release.
- Submit and review change controls to determine the level of change and consequent submission requirements.
- Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. May lead a departmental project team.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Influences middle management on technical or business solutions.
- May interact with vendors.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) math, engineering, or medical fields is preferred
- 2-3 years of experience in a regulated industry (e.g. medical products, nutritional's)
- Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
- Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process.
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Regulatory Affairs Specialist
Found in: Appcast US C2 - 3 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 ...
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Regulatory Affairs Specialist
Found in: Appcast US C2 - 4 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 ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 1 day 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 ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 5 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 ...
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Regulatory Affairs Specialist
Found in: ZipRecruiter Priority US C2 - 1 day 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 ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 2 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 ...
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Regulatory Affairs Specialist
Found in: Appcast US C2 - 6 hours 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, ...
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Regulatory Affairs Specialist II
Found in: Appcast US C2 - 5 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 ...
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Regulatory Affairs Specialist II
Found in: ZipRecruiter Test10P US C2 - 1 day 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 ...
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Specialist Regulatory Affairs
Found in: Appcast US C2 - 1 day 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 ...
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senior clinical specialist, medical affairs
Found in: Careerbuilder One Red US C2 - 1 day ago
ICU Medical Inc. Mettawa, IL , USA, United StatesPosition Summary · The primary function of the Senior Clinical Specialist is to support the development of new and existing products for ICU Medical, Inc. The Senior Clinical Specialist provides clinical support to internal and external customers and provide the voice of the cust ...
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Regulatory Affairs Specialist II - 3 Openings
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 ...
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Regulatory Affairs Specialist
Found in: Appcast Linkedin GBL C2 - 7 hours ago
ProKatchers LLC Des Plaines, United StatesJob Title: Regulatory Affairs Specialist · Location: Des Plaines, Illinois, United States · Duration: 08 Months · Job Description: · Description: · Must have 1-2 years of experiences in Medical Device Reg Affairs · Have working knowledge in EU MDR Have working knowledge in Regul ...
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Regulatory Affairs Specialist
Found in: Appcast US C2 - 1 day ago
Kelly Science, Engineering, Technology & Telecom Round Lake, United StatesKelly Science & Clinical is seeking a Regulatory Affairs Ops Specialist near Round Lake, IL. · Long term contract = ~1 year contract · Shift: Monday - Friday 1st · Hybrid - 3 days onsite, 2 remote · Compensation: based on experience · Responsibilities: · Managing the preparatio ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 5 days ago
ProKatchers Des Plaines, United StatesJob Title: Regulatory Affairs Specialist · Location: Des Plaines, Illinois, United States · Duration: 08 Months · Job Description: · Description: · Must have 1-2 years of experiences in Medical Device Reg Affairs · Have working knowledge in EU MDR Have working knowledge in ...
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McCain Foods Villa Park, United StatesPosition Title: Regulatory Affairs Specialist · Position Type: Regular - Full-Time · Position Location: Oakbrook Terrace · Requisition ID: 28326 · The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished goods manufactu ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 2 days ago
Direct Recruiters Chicago, United StatesOur client is a global leader in ink and laser marking/coding industrial equipment manufacturing. They are seeking a Regulatory Specialist for the Fluids (inks) business unit. · Looking for strong experience as a Regulatory Specialist or Product Steward for CHEMICALS/HAZARDOUS M ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 4 days ago
Direct Recruiters Chicago, United StatesOur client is a global leader in ink and laser marking/coding industrial equipment manufacturing. They are seeking a Regulatory Specialist for the Fluids (inks) business unit.- Looking for strong experience as a Regulatory Specialist or Product Steward for CHEMICALS/HAZARDOUS MAT ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 2 days ago
Direct Recruiters Chicago, United StatesOur client is a global leader in ink and laser marking/coding industrial equipment manufacturing. They are seeking a Regulatory Specialist for the Fluids (inks) business unit. · Looking for strong experience as a Regulatory Specialist or Product Steward for CHEMICALS/HAZARDOUS M ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 5 days ago
SPECTRAFORCE Round Lake, United StatesTitle: Regulatory Affairs Ops Specialist · Duration: 12 Months · Location: Round LakeIL, 60073 · Hybrid - 3 days onsite, 2 remote · Description: · Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types · Cr ...
Regulatory Affairs Specialist - Lake Forest, United States - GForce Life Sciences
Description
Regulatory 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 processes and environment. This candidate will assist in the registration of products by preparing and submitting necessary documentation for registration worldwide.
Day-to-Day Duties
Mandatory Requirements
Nice to have
Term & Start
· 12-month contract with possibility to extend
· FT, M-F 40h/week
· Pay Rate: $25-30/hr ($50-60K annually)
· Onsite in: Lake Forest, IL
