Clinchoice Inc.
Regulatory Affairs Specialist Consultant
Canada
Sponsorship not specifiedDetected 121 days ago
AccessibilityExcelFDA RegulatoryMedical DevicesCommunicationCritical ThinkingOrganizational SkillsMicrosoft OfficeRegulatory Affairs
Stay score
odds of building a lasting career here
40Risky
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 90%
Of 10 labor certifications old enough to have been used, 1 expired without the employer filing the next step. Median time from filing to decision: 490 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?
- Our team says it's the best of both worlds….
- ClinChoice is searching for a Regulatory Affairs Specialist Consultant with Hybrid option in CANADA for 12 months CONTRACT and renewable, to join one of our major consumer products clients.
Responsibilities
- Prepare and/or review of letters of authorizations, cover letters for registration certificates, declarations, power of attorney, etc., to ensure accuracy, appropriateness and consistency of documents intended for various regulatory submissions.
- Extract available documents from the document management databases and operational systems to assist in the preparation of dossiers.
- Maintain various tracking tools to ensure up to date information and traceability of all regulatory data/documentation.
- Filing and retrieving documents as directed and per company's policies and procedures.
- Provide support to internal and external teams to address various technical inquiries and provide requested information.
Requirements
- Strong organizational skills including attention to detail, good planning and communication skills are required
- Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
- We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
- Minimum of three years of working experience in regulatory affairs in preparing and reviewing technical documentation and submissions per Health Canada medical device regulations
- Basic knowledge of EU MDD/MDR and ISO13485 or equivalent education is preferred.
- Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
- Have good understanding of current Good Documentation Practices in regulatory environment
- Must possess excellent written and verbal communication skills
- Detail oriented with strong critical thinking and analytical skills and keen on producing results
- Who will you be working for?
- About ClinChoice
- ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
- Our Company Ethos
Compensation
- The base salary pay range represents the anticipated low and high range for this position.
Benefits
- Prepare, review, and support medical device registration submissions and post-market regulatory activities.
- ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
- Join our passionate team and make a meaningful impact on global healthcare!
Company info
- We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
- We are committed to inclusive, barrier-free recruitment and selection processes.
Visa & Work Authorization
- Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?
Apply directly at Clinchoice Inc. →Create a free account for alerts like thisView Clinchoice Inc. immigration profile
This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.