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Senior Regulatory Affairs Program Lead - Medical Devices

Employer
ClinChoice
Location
Jacksonville, United States
Salary
Competitive
Start date
21 May 2024
Closing date
20 Jun 2024

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Senior Regulatory Affairs Program Lead - Medical Devices

at ClinChoice (View all jobs)
Jacksonville, Florida, United States

Location: Jacksonville, Florida, United States - Hybrid (2 days per week from office)

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 Senior Regulatory Affairs Program Lead - Medical Devices to join their internal team in the United States. You will be responsible to administer day-to-day Regulatory Affairs department activities by directly or indirectly managing individual employees, teams of employees, or third-party vendors. 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 primary responsibility of this individual is to administer day-to-day Regulatory Affairs department activities by directly or indirectly managing individual employees, teams of employees, or third-party vendors. In addition, these roles exhibit a high degree of independent judgment and execute on plans that directly impact the operational results of business units. This position may have direct supervisory responsibilities.
Adheres to environmental policy, procedures, and supports department environmental objectives.

Main Job Tasks and Responsibilities:

Under limited supervision, the Senior Regulatory Affairs Program Lead will be responsible for:
A. Provides tactical and strategic regulatory leadership to the organization and oversees regulatory aspects of new product development and launches including the preparation and submission of required global regulatory submissions.
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.
B. Independently makes decisions regarding work processes or operational plans and schedules
C. Provides day-to-day instructions and suggested training activities to direct reports; assigns projects or activities to individual contributors.
D. Represents regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.

Education, Experience and Skills:

Minimum education required for competent performance:
• Bachelor’s Degree or equivalent
• Minimum of 6-8 years related work experience
B. Proper application of Title 21 of the US Code of Federal Regulations
C. Proper application of Part 800-1299 (21 CFR 800-1299)
D. Proper application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
E. Proper application of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and European Union Medical Device Regulation (MDR) 2017/745
F. Proper application of Quality Management System Standard ISO 13485
G. Proper application of Risk Management Standard ISO 14971
H. Familiarity with International Medical Device requirements (Canada, China, Japan, Australia, Brazil, Russia, etc.)
I. Excellent written and oral communication skills.
J. Good analytical thinking, problem solving and investigative skills.
K. Proficiency in Microsoft Office and all related applications

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: New Product development, Project Management, Medical devices, International registrations, Technical Dossiers, Regulatory licenses.

#LI-PR1 #LI-HYBRID #Senior #FULLTIME

Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
GB

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