About this role
- As a clinical Affairs Consultant you will be playing a pivotal role in overseeing the quality and scientific integrity of studies, involved in all steps of the clinical research protocols and working with the team to perform required procedures of studies.
- Supporting regulatory compliance performing the required activities that assure compliance with FDA regulations for class III products.
- Is a subject matter expert in Clinical and or Regulatory Affairs, evolving regulatory landscape.
- Responsible for handling or supporting regulatory requests from regulatory agencies.
- Preparing and /or reviewing submissions to FDA and other regulatory bodies.
- Maintaining registrations and device listings.
- Supporting the reporting of departmental metrics.
- Supporting and backup for other Q&R functions.
- Supports internal/external audits and regulatory inspections.
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
- Minimum 15 years professional experience in the applicable role.
- Education: Bachelor's /Masters/ may require M.D. or D.O.or equivalent combination of education and experience.
- Expert and technical lead with proven experience.
- May require licensure and certifications in area of specialization.
What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
- Vacancy number: PUB246225
- Location: Andover
- Market: Life Sciences & Health Care
- hours per week: 40
- Branch: Health Care
- Education level: Academic Master +
- Area of Expertise: Clinical
- Closing date: Friday, February 7, 2020
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