Senior Manager, Medical Devices / IVD
Company: PharmaLex
Location: Burlington
Posted on: March 20, 2023
Job Description:
PharmaLex is one of the largest providers of Development
Consulting and Scientific Affairs; Regulatory Affairs; Quality
Management & Compliance; and Pharmacovigilance, Epidemiology and
Risk Management worldwide. Through our US, European and
Asia-Pacific offices, our trusted consultants provide specialized,
regulated services to pharma, biotech and MedTech industries to
help them successfully meet the regulatory challenges of bringing
products to market and helping them to maintain their product
portfolios following launch. - -We are currently looking for an
experienced professional to support Medical Devices Services (MDS)
division for PharmaLex US. This role is responsible for supporting
the MDS Director on strategic and business development, day to day
direction and the MDS teams. -PharmaLex is a proud to be an equal
opportunity employer. - We respect and seek to empower each
individual and support the diverse cultures, perspectives, skill,
and experiences within our workforce. - We believe that diversity
and inclusion among our teammates is critical to our success as a
global company and we seek to recruit, develop and retain the most
talented people from a diverse candidate pool. -As a Key
Contributor You Will
Accountability for the execution of
projects in the field of regulatory, technical and quality
management consulting predominantly in the medical device and
diagnostic sectors. - Support more senior colleagues with their
client-related work and assist junior colleagues as
required.Support the organization with any relevant operational
needs. -Reports to (title): Director / Senior Director, MDS
USATravel expectations (in %): 5% -Key Responsibilities and
Activities
Advising, supporting, managing
regulatory, technical and quality management consulting projects
for clients in the medical devices and diagnostic
sectors.Supporting PharmaLex staff and their customers in the
implementation of medical devices and diagnostic regulatory
strategies.Ensuring optimal licensing for marketing and regulatory
compliance of complex products.Preparing, revising and compiling
product information for clients (e.g. IFUs, PIL, labels).Creating,
revising, editing and maintaining technical dossiers and regulatory
documentation for clients. Preparing and participating in
Scientific Advice Meetings with regulatory authorities.Preparing
and presenting seminars and lectures within their area of expertise
to PharmaLex-internally and to clients and professional
audiences.Communicating with the client and the Health Authorities
within area of expertise (e.g. jurisdiction, process or
product).Training and mentoring less experienced colleagues in
consulting practices, regulatory frameworks and in client project
work.Contributing to the optimization of departmental internal
processes.Actively contributing to the sharing of knowledge within
the Medical Device / IVD department.Participating in strategic
regulatory issues (e.g. Regulatory consultations).Supporting the
preparation, quotation and invoicing o of Projects in close
cooperation with the respective Project Lead.Providing support to
more senior colleagues in complex or strategic client-related work,
including representation at business development meetings,
conferences and in marketing activities. -Key Decisions made by
roleWithout checking with your supervisor
Day-to-day client interaction and
project portfolio managementDelivering consultancy services as per
agreed Statement of Works (e.g. regulatory research, report
compilation, technical advice)Identifying next project steps with
Clients and participating in the establishment of relevant
Statements of WorkDirectly managing service delivery within the
project scopes, budgets and raising project risks to
supervisorSupporting junior and senior staff with their project
workReadily sharing knowledge in relevant technical disciplines
(e.g. Regulatory, Quality Assurance and technical fields)Suggesting
Quality System modifications, document revisions and internal
auditAfter checking with your supervisor
Supporting internal Quality System
activities (e.g. CAPAs, Audits) as per operational needsAttending
or participating in conferences, industry working groups and
consultations, etcAssisting with the preparation and delivery of
training sessionsInitiating new client contactsReleasing new
Statements of Work to ClientsConducting business development
activities and other significant business-related activities
Delivering business-critical advice to clients (e.g. commercial &
compliance strategies)Actions recommended to your supervisorActing
on new business development and marketing activities - -Actions
recommended to your supervisor
Releasing high value client
reportsRaising opportunities related to business operations,
service promotion and structureRecommending staff development needs
-Required Education, Experience, Skills and Competencies
University degree in Science or
Engineering6 + years in regulatory and/or quality management in
medical device, diagnostics, biotechnology or related consulting
environment.Hands-on experience in the preparation of regulatory
and technical submissions, reports and documentation or in the
implementation of quality management systems (e.g. ISO 13485, ISO
9001, 21 CFR 820, MDSAP or equivalent), preferably in the medical
device or diagnostics environment.Sound understanding of local and
international regulatory and compliance legislation and
requirements.Ability to efficiently obtain and review information
from a range of sourcesAbility to interpret, analyse, plan, write
and apply appropriate legislation, regulatory, technical and
quality requirements.Ability to identify and understand the
commercial context of Clients and make project decisions
accordinglyAbility to prepare regulatory documents and reports that
are accurately referenced, with appropriate citation and written in
cohesive manner to optimise outcomesIdentify up selling
opportunities within their project portfolioComplex problem-solving
abilities, strong understanding of the consulting
businessStructured, analytical, systematic and independent approach
to workTeam player with collaborative work style and willingness to
knowledge shareClient orientationEffective written and spoken
communication skills with internal and external customers,
colleagues and supervisorsFlexible and adaptableExperienced user of
the MS-Office package, Adobe Acrobat and database systemsEnglish
language fluency, written and spoken -*This is a remote position.
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Keywords: PharmaLex, Boston , Senior Manager, Medical Devices / IVD, Executive , Burlington, Massachusetts
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