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Regulatory Affairs Specialist IV

In Massachusetts / United States

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Regulatory Affairs Specialist IV   

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JOB TITLE:

Regulatory Affairs Specialist IV

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Andover Massachusetts / United States

JOB DESCRIPTION:

Responsibilities:Prepare submission/compliance strategy documents in line with specified timeframes.Supports the generation of technical documentation and the writing and compilation of technical files.Works with cross functional teams – with senior support - to deliver supporting documentation (IFU, DHF, CER etc.)Reviews and approves labelling and instruction for use.Supports and implements the global market change programHelp maintain licenses, manage legacy TF updates (removal of SKUs as they transition to MDR)Licenses/ Certifications: None required, ISO Auditor certification and or RACs preferred.EDUCATION and/or EXPERIENCE:3-5 years experience in regulatory affairs. Knowledge of current EU regulations is preferred. Knowledge of orthopaedic devices preferred.LANGUAGE SKILLS:Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence. Ability to effectively present information and respond to questions from groups of managers clients, customers and the general public.MATHEMATICAL SKILLS:Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.REASONING ABILITY:Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Competences: Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, ability to communicate effectively and work within international multidisciplinary team.Shortlisting requirements:3-5 years experience in Regulatory AffairsLabeling update experienceTechnical file experience preferredDesign control documentation review experience

Position Details

POSTED:

Sep 03, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S1657184408219774

LOCATION:

Massachusetts / United States

CITY:

Andover

Job Origin:

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Responsibilities:Prepare submission/compliance strategy documents in line with specified timeframes.Supports the generation of technical documentation and the writing and compilation of technical files.Works with cross functional teams – with senior support - to deliver supporting documentation (IFU, DHF, CER etc.)Reviews and approves labelling and instruction for use.Supports and implements the global market change programHelp maintain licenses, manage legacy TF updates (removal of SKUs as they transition to MDR)Licenses/ Certifications: None required, ISO Auditor certification and or RACs preferred.EDUCATION and/or EXPERIENCE:3-5 years experience in regulatory affairs. Knowledge of current EU regulations is preferred. Knowledge of orthopaedic devices preferred.LANGUAGE SKILLS:Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence. Ability to effectively present information and respond to questions from groups of managers clients, customers and the general public.MATHEMATICAL SKILLS:Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.REASONING ABILITY:Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Competences: Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, ability to communicate effectively and work within international multidisciplinary team.Shortlisting requirements:3-5 years experience in Regulatory AffairsLabeling update experienceTechnical file experience preferredDesign control documentation review experience


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