The Director of Regulatory Affairs will support product development, registration, and post market support activities, in addition to managing a small team of Regulatory Affairs Associates and directing their work as it relates to the activities outlined below.
Support Product Development & Registration:
Provides strategic
input
and technical guidance on global regulatory
requirements
to product development and clinical teams
.
Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
Evaluates proposed preclinical
,
clinical and manufacturing changes for regulatory
filing
solutions and proposes plans for changes that do not require subm
i
ssions
.
Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
.
Monitors
implementation of regulatory strategies
relative
to
product
and clinical safety
issues identified
during clinical phases.
Provides knowledge and critical analysis of preapproval inspections
,
GCP inspections and clinical
investigator
relationships
.
Provides regulatory guidance on strategy for proposed product claims/labeling
.
Ensures clinical and nonclinical data are consistent with the regulatory requirements and
suppo
r
t the proposed product cla
i
ms
.
Manages
e
lectronic and paper registration development.
Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
.
Prepares cross-functional teams for interactions with regulatory authorities
i
ncluding panel meetings/advisory committees
.
Support Post approval/Post market Activities:
Ensures process is in place for review and approval of advertising and promotion to ensure regulatory compliance
.
Develops
,
implements, and manages systems to track required reports
,
supplemental submissions, and other post marketing commitments
.
Reviews and approves required reports
,
supplemental submissions, and other post marketing commitments to maintain product regist
r
ations
.
Reviews and app
r
oves change contro
l
s to determ
i
ne the level of change and consequent submission requirements
.
Develops
,
implements, and manages appropriate SOPs and systems to track
,
manage, report, and communicate product
-
associated event complaints
,
recalls
,
market w
i
thdrawals and vigilance reports
.
Adapts post market strategy based on consideration of factors such as HTA
,
reimbursement
,
group purchasing pressures
,
state/provincial/ regional restrictions, and other legislative/regulatory requirements
.
Other Responsibilities
Serves as company
'
s deputy Person Responsible for Regula
t
ory Compl
i
ance (PRRC)
.
Participates in Corporate initiat
i
ves as appropriate
.
Supports Quality Policy and Quality System
.
Requirements:
Bachelor
'
s degree and a min
i
mum of 12 years of experience
i
n Regulatory Affairs in the med
i
cal device industry.
Demonstrated strength in regulatory submissions activities
. Class III, PMA experience is strongly desired.
Commercial and post-market experience is required.
Knowledge of international regulatory requiremen
ts, EU MDR.
Strong
project management skills and e
x
perience
.
Proficient in timely review of technical data and clinical data
.
Demonstrated success
i
n fast-paced start-up
,
entrepreneurial work environments.
Ability to write clear
,
concise
,
and well thought out technical documents
.
Strong leadership
,
organizat
i
onal
,
interpersonal sk
i
lls.
Excellent presentation skills
.
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