Staff Regulatory Affairs Specialist
SpectraForce Technologies - Sandy, UT

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Job Title: Staff Regulatory Affairs Specialist

Job Description:
Qualifications:
Level of Independence: Independently manages multiple long-term projects without direct supervision. Interacts with manager as required on activities, issues, or milestones. Leadership & Direction: Inspires effective unit dynamics and imparts a sense of commitment to unit goals. Encourages and empowers others to achieve. Planning and Control: Formulates short-term planning for individual deliverables and participates in long term planning within the unit. Strategic Impact: Influences content in the functional scorecard, including the development and definition of measurable goals and objectives consistent with business and operating plans. Education & Experience Professional Status: A BA/BS degree is required. Preferred education/experience areas include health care, clinical, engineering, physical, biological, and regulatory sciences, potentially coupled with advanced degrees (, MBA, PhD, etc.) and certifications (RAC, CQA, C

Responsibilities:
The Staff Regulatory Affairs Specialist will represent regulatory affairs on new product development teams, sustaining engineering teams, and other product development initiatives. The Staff Regulatory Affairs Specialist will provide these teams with strategic and tactical guidance regarding submission requirements to support product approvals in the US and EU. This individual will liaise with Becton Dickinson regulatory professionals outside of the US and EU to determine product approval requirements, globally, and communicate these requirements to the product development teams. The Staff Regulatory Specialist will create regulatory strategies, review and approve labeling/promotional/advertising materials, ECOs, PDNs, and other documents to ensure compliance to the appropriate regulations. This individual will prepare the appropriate regulatory submissions and interact with health authorities to obtain and maintain product approvals in the US and EU

Skills:
Skill RequirementsExp (Mos.)Comments

Degree Type:
Degree TypeMajorRequiredPreferred
High School
Bachelor
Master

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