Our client is a family-oriented, flexible organization that allows
their employees to balance their personal lives with providing their
clients with first-rate consulting services in the biotech and medical
device industries. This position will provide senior level support to
project teams in the areas of regulatory affairs and quality
assurance.
Responsibilities will include:
* Managing pre-approval regulatory procedures including meeting with
FDA on pre-IDE's and IDE's, proposing regulatory strategies to reduce
the size of trials.
* Participating in PMA presentations and prepping senior management
for PMA presentations.
* Managing and participating in client audits, including both
regulatory and quality audits.
* Managing the preparation of document packages for regulatory
submissions.
* Developing and reviewing SOP's for clients and participate in the
ongoing SOP review process.
* Providing regulatory review of quality system assessments
* Participating in regulatory document preparation.
* Participating in project budget preparation.
* Project management skills such as the ability to coordinate
assignments, complete assignments within established timelines,
refined and independent problem solving ability, and attention to
detail.
Your background:
* B.A./B.S. in a science related/health field.
* Work experience in regulatory affairs with a medical device company
or as a consultant in the medical products industry
* Excellent organizational, interpersonal and communications skills.
* Ability to work independently while generating quality project
deliverables.
* Willingness to travel as project dictates.
Plenty of companies pay lip service to providing honest work-life
balance and providing world class service to their customers, our
client delivers on that promise which creates a rewarding, fulfilling
work environment.
To learn more contact:
Tom Doane
Senior Recruiter
The Suburban Group, Inc.
508-366-8521
Thomas.Doane from suburbangroup.com
