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Senior Regulatory Affairs Specialist

4 months ago

Jacksonville, United States ClinChoice Inc. Full time

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

Senior Regulatory Affairs Specialist (Medical Devices)

Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

POSITION SUMMARY

Guided by supervision, the individual in this role provides regulatory support in a number of areas, including but not limited to:

A.

Reviewing/analyzing modifications to product, manufacturing process, packaging, etc. to determine impact of registration status of approved products and to determine appropriate regulatory pathway. B.

Reviewing and approving advertising and promotion materials C.

Performing re-registration activities to support registrations Outside of the United States (OUS) D.

Assisting in developing regulatory strategies for new product development initiatives. E.

Performing regulatory operations tasks including archiving/assembling/publishing regulatory filings and other health authority communications. Adheres to environmental policy, procedures, and supports department environmental objectives.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES

Under supervision, the Senior Regulatory Affairs Specialist will be responsible for: A.

Coordinating and submitting registrations for maintenance of existing products, including international registrations, updates to Technical Documentation Files, Declarations of Conformity, etc. B.

Reviewing engineering/device change requests. C.

Researching, collecting data, responding to requests from regulatory agencies to prepare and submit documentation for US and OUS marketing clearances/approvals, as well as to provide routine information to business associates and their affiliates. D.

Provides regulatory guidance to various internal teams/department personnel and responds to regulatory related product requests. E.

Represents the regulatory affairs department in cross-functional project teams, plans and schedules regulatory deliverables to achieve project milestones. F.

Prepares associated product labeling to meet registration requirements for new or modified products; reviews product labeling associated with existing product to ensure compliance to regulatory requirements. G.

Assists in development of best practices, work instructions for Regulatory Affairs processes and H.

Provides Regulatory Affairs support for internal and external quality system audits.

QUALIFICATIONS Minimum education required for competent performance: Bachelor’s Degree - Scientific Discipline (preferred)

Minimum of 3 years of work experience within the Medical Device or Pharmaceutical industry or 0-3 years with a PharmD/PhD. Strong communication, organizational, negotiation and interpersonal skills

General knowledge, understanding and application of principles, concepts and practices related to FDA regulations. Regulatory knowledge to maintain legal status of products and minimize risk. Broad based technical knowledge and skills in diverse business functions (e.g., R&D, Operations, QA, laboratories, marketing, etc.) are a plus. Self-motivated and committed to a team focused approach to problem solving. Ability to organize and analyze technical data and identify issues or gaps. Ability to provide innovative solutions within the boundaries of regulation.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

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.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.

The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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