|
|
A Division
of
GMP
Publications
& FDA.COM
"The GxP Family of
Quality Business"
|
|
"We stand on a higher pillar of excellence!"
|
Title |
Location |
Type |
Rate |
Apply Now |
| Manager of
Regulatory Affairs 3386 |
Rochester,
NY |
Perm/Full |
$75,000 -
$105,000 |
Submit Resume |
Manager of Regulatory Affairs
Provide Regulatory Affairs management for
various projects, to include 510(k), PMA, IDE,
label/advertising review, and other regulatory
affairs support activities.
Job Duties:
Develop Regulatory strategies and timelines for
product development and product improvement
projects.
Lead and prepare US and non-US product
submission projects such as 510(k), PMA, IDE,
and CE technical files. This requires
participation in product development teams, a
well as responsibility to review, analyze, and
comment on technical reports.
Review, approve, and provide guidance for
labeling and advertising of the Company device products.
Counsel technical and business groups to
establish direction based on available data and
regulatory considerations.
Provide review and guidance of failure
investigations and corrective actions referred
to Regulatory Affairs. Provide guidance on
regulatory compliance.
Review and approve policies and procedures.
Interact with US and non-US government officials
on product approval and compliance issues.
Provide input and comment to regulations and
standards which may affect the Company device products.
Participate in industry working groups on
advocacy initiatives.
Qualifications Education: BA/BS degree in a
technical or scientific discipline such as
biology, chemistry, physiology, engineering,
medical or law. Advanced degree or additional
professional training would be of value.
Experience: Minimum 5-7 years experience in
Regulatory Affairs with a demonstrated
capability and experience preparing submissions
for US Class II/Class III medical devices, as
well as non-US medical device registrations. 10+
years experience in the Medical Device or Drug
Industry desired. Knowledge of medical device or
drug GMPs desired.
Special Skills: Must have excellent
communication, organization, time management and
writing skills. Strong interpersonal skills
required in areas of verbal and written
communications, service to internal customers,
professionalism, coaching, influencing, and team
building. Strong questioning and problem-solving
skills. Must be self-motivated by working
independently and having the ability to take
ownership of his/her responsibilities. Should
have mathematical skills commensurate with
educational background, and necessary for
describing and summarizing laboratory and/or
clinical data in product registration
submissions.
Language Skills: Must have command of English
language. Ability to read, analyze and interpret
governmental regulations, general business
periodicals, professional journals and technical
procedures. Ability to write routine reports and
business correspondence. Ability to effectively
present information in one-on-one and small
group situations, to internal customers and
other employees of the organization. Ability to
communicate well with all levels of the
organization.
Specialized Training: Computer literate with
general office software and internet use.
Work Location NY - Rochester |
|
|
|
|
