Assoc Regulatory Affairs Spec

Looking for someone who has international background with good regulatory affairs knowledge, very detail oriented and capable of working under pressure.

Position summary:

· The Regulatory Affairs Admin/Coordinator is a key position in regulatory affairs as this individual will provide the necessary administrative and coordination support to the Global Regulatory Affairs department at Covidien Neurovascular.

· The responsibilities of this role cannot be emphasized strongly enough as the support required will directly influence the successful preparation, submission, receipt and maintenance of all Covidien Neurovascular product registrations and regulatory intelligence globally.

· The Regulatory Affairs Admin/Coordinator will be the face and voice of the Regulatory Affairs department to internal as well as external customers.

· As such, this role requires an individual with demonstrated skills in communication and professionalism.

Principal accountabilities:

· Regulatory Submission/Approval Intelligence Manage product registration global approval data

· Manage regulatory global dashboard Regulatory Document Legalization

· Acquire necessary Notarizations and Authentications needed for regulatory filings from appropriate US and foreign government Offices Regulatory Submission Assembly/Shipping

· Coordinate regulatory submission publishing for efficiency

· Assist team with electronic and hard-copy submission compilation, assembly and shipping

· Shipping Release Authorization (SRA/GTS)

· Coordinate and manage SRA process from regulatory perspective

· Coordinate timely opening and closing of GTS regulatory tables and ensure compliance to approval evidence

Experience:

· Knowledge and understanding global regulations and requirements for medical devices, desired.

· Proficiency in use of Microsoft Office Suite computer software

· Proficiency in the use of Adobe Acrobat

· Professional computer software

· Strong written and verbal communication skills, including ability to communicate with individuals who do not speak English as their primary language

· High attention to detail and accuracy

· Skill in obtaining facts that assure information is complete and accurate.

· Ability to plan and prioritize work and balance multiple projects

· Skill in the completion and follow through of projects

· Ability to maintain satisfactory working relationships Notary Public or desire to obtain

Education:

· Medical device industry/legal experience desired.

· Associate's degree (AA/AS); Bachelors degree desired.

· Experience in Regulatory Affairs preferred.

To know more about this position, please contact:

Vishnu Gopalakrishnan
973-606-3255