Regulatory Affairs Support
REFERENCE RA 2019
REFERENCE RA 2019
Profile Introduction
Our
client, an International Company, dealing with the provision of solutions in
energy, healthcare, transportation and finance is seeking to recruit a
Regulatory Affairs Support.
Role Summary
·
The Regulatory Affairs Support –
Region may be involved in Pre or Postmarket duties or both. They will work with
a team of Regulatory Affairs professionals and provide support to ensure the
Organization Health Care establishes and implements best practice processes and
procedures in premarket and post market support.
·
He/she ensures accurate and optimal
submissions of regulatory reports that meet the requirements of the region or
country
Qualifications
·
Bachelor’s Degree (or internationally
recognized equivalent) in a related field such as: Regulatory Science,
Biomedical Engineering, Biology, Chemistry, English (with a technical writing
emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical
Science, Pharmacy
·
Minimum of 4 years progressive
regulatory affairs experience in medical device or pharmaceutical industry or
medical product regulation agencies, including knowledge and experience
applying drug or device laws and regulations
·
Experience in a medical device or
pharmaceutical industry
·
Strong analytical skills
·
Ability to work in a team environment
with minimal supervision on projects and activities
·
Ability to prioritize, plan &
evaluate deliverables
·
Knowledge & experience conducting
scientific, regulatory, legal, or business research.
·
Excellent verbal and written
communication and presentation skills with the ability to communicate in English
in an easy to understand manner
·
Experience using spreadsheet and
presentation software
Responsibilities
·
File and maintain regulatory
deliverables
·
Analyze and communicate changes and
proposed changes to country regulations through Regulatory Intelligence and
implement strategies
·
Support regulatory inspections as
required
·
Support regulatory compliance and
optimization of quality system procedures relating to new product registration
submissions and post market reporting through the development, maintenance and
improvement of documented processes.
Premarket
·
Create regulatory compliance /
project plan with Product RA to ensure all requirements are met for country
submissions and liaise with relevant personnel to ensure appropriate, timely
input is provided for submissions
·
Communicate with Product RA to
establish regulatory requirements, including clinical trial data.
·
Complete specific country testing and
work with Product RA; arrange for test devices and support as needed.
·
Provide RA oversight to clinical studies
to ensure regulatory requirements are met
·
Partner with Product RA to review
advertising and promotion materials for country or regional compliance and
approve these as required.
·
Act as liaison with external
regulatory reviewers to gain rapid approval of submissions.
·
Work with Product RA for countries
with license expiration requirements; establish plan and deliverables for
timely submission for renewal of license
Postmarket
·
Monitor external information for
incidents or issues that may involve the organizations Health Care products;
communicate information internally in a timely manner.
·
Liaise with relevant personnel to
ensure appropriate, timely input is provided for post market reports.
·
Review field action information to
determine if reportable in local country.
·
Liaise with external regulatory
bodies, as required, to ensure appropriate and timely responses are provided to
inquiries regarding product reports.
Competencies
·
Advanced degree in scientific,
technology or legal disciplines.
·
Experience in a medical device or
pharmaceutical industry.
·
Knowledge of Quality Management
Systems (QMS).
·
Experience working across
cultures/countries/sites.
·
Demonstrated experience interfacing
with regulatory agencies including PPB; TFDA, MHLW, Health Canada, etc. and standards
bodies such as KEBS, TBS, AAMI, IEC, ISO, UL.
·
PPB credentials for accessing PPB
online portal.
·
Demonstrated experience prioritizing
conflicting demands from multiple business entities in an extremely fast paced
environment.
·
Demonstrated understanding of
healthcare environment and knowledge of current competitive, commercial or
political situations and their impact on the Organization Healthcare regulatory
Cash Collector
REFERENCE CC 2019
Profile Introduction
Our
client, an International Company, dealing with the provision of solutions in
energy, healthcare, transportation and finance is seeking to recruit a Cash
Collector
Qualifications
·
Bachelor’s Degree in Business Course
majoring in finance
·
3+ years’ experience in Debt
Collection.
·
Experience of work with multiple
teams (Experience with multiple East Africa countries added advantage)
·
Sound computer skills: Excel is
required
Responsibilities
Collections
·
Build relationships with customers
aimed at enabling timely payment, issue resolution and building compliant
processes
·
Customer contact for early
collection, escalation and resolution to ensure collection per payment terms
·
Resolve customer inquiries promptly
& accurately, by understanding customer market & needs
·
Proactively and timely partner with
P&L, finance & operations teams to drive past dues reduction
·
Support prompt customer resolution of
issues; proactively raise customer disputes, initiate escalations and follow up
on snag for timely resolution
·
Manage assigned portfolio and set
collections targets including review of client data, patterns and key trends
·
Proactive follow up on timely and
accurate cash application through provision of support
·
Delivery of manual customer invoices
and dispatch of statements
·
Identify and log customer complaints,
disputes in the system
·
Be responsible for customer financial
order approval/releases (if needed), by balancing the needs of the customer
with the financial realities of their liquidity
·
Have a controllership overview of the
dunning cycle/letters
·
Deposit/Banking of customer cheques
where the need arises
·
Support Cash Application team
gathering payment details from customer and reconcile account if needed.
·
Accomplish all responsibilities in
line with Organization’s compliance and integrity requirements Reporting, Metrics
+ Op. Mech.
·
Ensure completeness of documentation
and weekly visibility of collectible and non-collectible AR
·
Track all non-collectibles, initiate
dispute tracking where applicable and provide accurate/complete details
·
Escalate all accounts with payment
risk and follow up for appropriate actions
·
Publish weekly AR status and
quarterly trends by customers as well as cash forecasts
·
Drive consistent metric definitions
& process for measurement across all platforms
Leadership + Controllership
·
Ensure compliance/adherence to Global
Enterprise Standards & Controllership guidelines
·
Coordinate O2C and WCS teams,
Organization businesses, Controllership & Compliance teams
Competencies
·
Ability to influence & work
collaboratively with matrixed teams
·
Strong communicator, building
relationships with internal partners & external customers
·
Knowledge of business revenue
recognition and Controllership policies
·
Willingness to drive issue resolution
& manage escalations
·
Ability to deal effectively with
rapid & changing priorities
·
Good communications skills to manage
stakeholder expectations
·
Ability to adapt quickly to changes
How to Apply
If
you are qualified and up to the challenge send your Resume and Cover Letter
to vacancies@stratostaff.co.ke by 22nd February 2019. Please note that only
qualified candidates will be contacted.