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Manager of Regulatory Affairs

1 month ago

Jacksonville, United States ClinChoice Full time

Manager of Regulatory Affairs - Medical Devices (HYBRID ROLE)

at ClinChoice (View all jobs)

Jacksonville, Florida, United States

Location: Jacksonville, FL or Irvine, CA - Hybrid (2 days per week from office) - HYBRID ROLE

Schedule: Permanent

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative one-team culture. We are looking for a dynamic person to join our in-house team as a Manager of Regulatory Affairs - Medical Devices to join their internal team in the United States. You will have the responsibility and authority to manage programs and/or projects in support of the regulatory demands of the business. Previous experience with a medical device industry is required.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career

POSITION SUMMARY

The Manager Regulatory Affairs has the responsibility and authority to manage programs and/or projects in support of the regulatory demands of the business. Positions at this level administer day-to-day Regulatory Affairs department activities by directly or indirectly managing teams of employees or managing third-party vendors. Combines knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Have department/site level influence and be generally recognized as an expert resource within the department. Identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance. Identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Utilize technical regulatory skills to propose strategies on complex issues. This position may have direct supervisory responsibilities.

Adheres to environmental policy, procedures, and supports department environmental objectives.

Main Job Tasks and Responsibilities:

With limited supervision, the RA Manager will be responsible for:

A. Provides tactical and strategic regulatory leadership to the organization and manages one or more regulatory programs, including continuous improvement activities, compliance related projects and/or new product development.

B. Leads projects, develops sound regulatory strategies for long-term registrations of new or modified products (e.g., 510(k)s, technical files, dossiers) for domestic and foreign submissions and registrations.

C. Leads in the understanding and awareness of the US, EU and other international regulatory requirements to ensure compliance.

D. Reviews and approves post-market changes, device labeling and marketing materials for compliance with applicable regulations

E. Interprets regulatory requirements and oversees aspects of submission of licenses and authorizations for the maintenance of existing products, international registrations and dossiers including assessment of the impact product changes have on the status of regulatory licenses.

F. Independently makes decisions regarding work processes or operational plans and schedules. Solves issues through information exchange, influence and active persuasion with or without direct authority to gain cooperation of other functions on program initiatives such as business development, life cycle management initiatives and/or new product development.

G. Provides day-to-day instructions and suggested training activities to direct reports, as applicable; assigns projects or activities to individual contributors.

Represents regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.

H. Prepares the responses to regulatory agency inquiries and other correspondence (either directly or indirectly through supervision of others)

I. Formulates policies for department/area of responsibility and responsible for recruiting professionals (as needed)

J. Ensures organization compliance with all applicable regulations and policies. Assists with audits and inspections, as required.

Education, Experience and Skills:

Typically requires BS with 8+ years of experience or Doctorate degree (e.g., PhD, PharmD, OD, JD) with equivalent experience.

Strong communication, organizational, negotiation and interpersonal skills. Expert knowledge, understanding and application of principles concepts and practices of government regulations. Ability to organize and analyze technical data and identify issues or gaps. Demonstrated skills in area of staff support and development (directly or indirectly). Foundational regulatory knowledge to maintain legal status of products and minimize risk. Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, laboratories, marketing, etc.) and ability to effectively negotiate and influence upper management, affiliates, and Regulatory agencies are a plus. Self-motivated and committed to a team approach.

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. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare

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 to 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.

Key words: Project Manager, Medical devices, Product registrations, Technical Dossiers, 510(k)s, International regulatory requirements.

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