Regulatory Compliance Coordinator, Belgium - L
- Employer
- ClinChoice
- Location
- Belgium
- Salary
- Competitive
- Start date
- 29 Sep 2022
- Closing date
- 28 Oct 2022
View more
- Discipline
- Regulatory Affairs, Compliance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Location: Belgium - Office based
Schedule: Full Time, Permanent
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Regulatory Compliance Coordinator to join one of our clients, one of the most innovative pharmaceutical companies in the world.
CROMSOURCE is an international 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 their client counterparts.
Main Job Tasks and Responsibilities:
- Assists with organizational tasks for the Compliance Solution Strategic (CSS) Regulatory Affairs Global Strategic Implementation Department
- Prepares Departmental meetings and documentation for audits sessions (logistics, formatting, meeting minutes)
- Supports department POs, managing regulatory fees (Ariba).
- Coordinates training in the Learning Management System (Compliance Wire)
- Acts as Records Management Coordinator, ensuring record retention policy and procedures are implemented
- Creates/revises quality systems documents (including but not limited to Change Orders on SOPs)
- Provides operational support for affiliates' requests to register products internationally
- Conducts searches of existing files for requested information. Liaises with the manufacturer to obtain all necessary documents and prepares regulatory documentation for submissions/registrations.
- Assists with the preparation of responses to regulatory agencies' questions and other correspondence.
- Assists with preparing necessary submission package for Certificate of Free Sales.
- Maintains regulatory databases, trackers, and systems
- Fulfills products distribution requests in accordance with Regulatory compliance status
- Assists in the execution of product labeling customization activities
- Assists in the development of best practices for Regulatory Affairs processes
- Provides solutions to a variety of problems of limited scope and complexity
- Responsible for communicating business-related issues or opportunities to the next management level
- Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety, and Environmental practices
- Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures
- Performs other duties assigned as needed
Education and Experience:
- University/Bachelor's Degree or Equivalent
- 0-2 years of work experience
- Experience in Regulatory Affairs or Quality Affairs preferred
- Knowledge of medical device regulatory requirements in the EU, Quality Management Systems, and experience in the Medical Device industry or medical field
Skills:
- Excellent written and verbal communications skills in English (required)
- Creative and good computer skills: Pack Office, Outlook, OneNote, TEAMS
- Ability to execute with attention to detail, meticulous, and apply Good Documentation Practices
- Ability to take on diverse tasks; executes under the direction of an expert and offers insight
- Ability to work in and with a diverse team
- Desire to learn and continuously improve
- Good organizational skills
The Benefits of Working for TalentSource in Belgium:
- Competitive Salary
- Group and hospitalisation insurance
- Electronic meal vouchers
- Internet reimbursement
- Company Car with fuel card depending on the function
- Dedicated Line Manager
- Regular face-to-face or phone meetings with the line manager
- Full annual performance review process
- Ad-hoc team events and end-of-year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a 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.
If you would like to discuss the role before applying through the website @
https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.
Who will you be working for?
About CROMSOURCE
CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE 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.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role, and work autonomously.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Regulatory Compliance Coordinator, Regulatory, Regulatory Affairs, Medical Devices, Pharmaceutical, Pharma, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated
Skills: Compliance Manager, Regulatory Affairs Associate, CRO, Medical Devices, Pharmaceutical, Regulatory submissions Location: Belgium Share:
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Company
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.
- Website
- https://clinchoice.com/
- Telephone
- +44 1628 566121
- Location
-
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom
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