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Senior Regulatory Affairs Specialist
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Job Description
- Req#: R9668
Employer Industry: Medical Device Manufacturing
Why consider this job opportunity:
- Salary up to $118,774.78 annually
- Opportunity for career advancement and growth within the organization
- Competitive benefits package including a 401(k) with up to a 6% employer match and no vesting period
- Flexible time off for salaried employees and generous vacation accrual for hourly employees
- Discretionary annual bonus and eligibility for long-term incentive plans
- Supportive and dynamic work environment with a focus on regulatory compliance
What to Expect (Job Responsibilities):
- Compile technical documents and author local regulatory submissions for FDA and Health Canada
- Provide guidance to product development teams on local product submission requirements
- Review labeling changes to assess regulatory impact on existing certifications
- Collaborate with cross-functional teams to develop regulatory approval strategies
- Conduct training programs on regulatory requirements and good regulatory practices
What is Required (Qualifications):
- Bachelor's degree required, preferably in STEM, Medicine, or Life Science
- Minimum of 2 years of Regulatory Affairs experience
- Strong understanding of regulatory compliance and submission processes
- Excellent communication skills for interacting with regulatory authorities and internal teams
- Ability to manage multiple projects and prioritize tasks effectively
How to Stand Out (Preferred Qualifications):
- Master's degree in Regulatory Affairs
- Experience with FDA and Health Canada submissions
- Familiarity with product registration databases and regulatory metrics
- Previous experience leading and directing teams
- Knowledge of vigilance issues and compliance programs
#MedicalDevices #RegulatoryAffairs #CareerOpportunity #CompetitivePay #EmployeeBenefits
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