Senior Regulatory Affairs Specialist 100% CDI

Responsibilities may include the following and other duties may be assigned.

. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
. Leads or compiles all materials required in submissions, license renewal and annual registrations.
. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
. Monitors and improves tracking / control systems.
. Keeps abreast of regulatory procedures and changes.
. May direct interaction with regulatory agencies on defined matters.
. Recommends strategies for earliest possible approvals of clinical trials applications.

Required Knowledge and Experience:
. Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, Clinical, or a related technical discipline.
. 4+ years of professional experience with a bachelor's degree, or 2+ years with an advanced degree.
. Experience working in a regulated environment (medical device, pharmaceutical, biotechnology, healthcare, manufacturing, clinical, or similar).
. Experience interpreting technical information, assessing risks, and making recommendations.
. Demonstrated ability to work independently and manage multiple priorities.
. Strong written and verbal communication skills.
. Experience collaborating with cross-functional teams and influencing stakeholders