Regulatory Affairs Specialist

Company Description

About Collabera
Collabera is the largest minority-owned Information Technology (IT) staffing firm in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 10,000 professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia) and the United Kingdom. We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers.

Not only are we committed to meeting and exceeding our customer’s needs, but we are committed to our employees’ satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for four consecutive years since 2012. With over forty offices globally and a presence in seven countries, Collabera provides staff augmentation, managed services and direct placement services to Global 2000 Corporations. Collabera is ranked amongst the top 10 IT staffing firms in the U.S., and for the past 24 years we have continued to grow rapidly year after year.

For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning. Visit www.collabera.com to learn more about our latest job openings.

Awards and Recognitions
--Staffing Industry Analysts: Best Staffing Firm to Work For (2015, 2014, 2013, 2012)
--Staffing Industry Analysts: Largest U.S. Staffing Firms (2015, 2014, 2013)
--Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US.

Job Description

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

Qualifications

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.

Additional Information

To know more about this position, please contact:

Vishnu Gopalakrishnan
973-606-3255