Assoc Regulatory Affairs Spec

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 includes 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.

We are committed to exceeding our customer’s needs and ensuring our employees’ satisfaction. Recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for four consecutive years since 2012, Collabera offers an enriching experience promoting career growth and lifelong learning. With over forty offices globally and a presence in seven countries, we provide staff augmentation, managed services, and direct placement services to Global 2000 Corporations.

We are ranked amongst the top 10 IT staffing firms in the U.S. and have experienced rapid growth over the past 24 years.

Visit  to learn more about our latest job openings.

• Staffing Industry Analysts: Best Staffing Firm to Work For )
• Staffing Industry Analysts: Largest U.S. Staffing Firms )
• Largest Minority Owned IT Staffing Firm in the US

We are seeking a candidate with an international background, good regulatory affairs knowledge, and a detail-oriented approach capable of working under pressure.

Position Summary:

• The Regulatory Affairs Admin/Coordinator provides administrative and coordination support to the Global Regulatory Affairs department at Covidien Neurovascular, directly influencing product registration and regulatory intelligence globally.
• This role serves as the face and voice of the Regulatory Affairs department to internal and external stakeholders, requiring excellent communication and professionalism skills.

Principal Accountabilities:

• Manage regulatory global dashboard and document legalization processes.
• Obtain notarizations and authentications for regulatory filings from US and foreign government offices.
• Coordinate regulatory submission publishing and assist with electronic and hard-copy submission assembly and shipping.
• Manage Shipping Release Authorization (SRA)/GTS processes from a regulatory perspective.
• Coordinate and manage the opening and closing of GTS regulatory tables, ensuring compliance with approval evidence.

• Knowledge of global regulations and requirements for medical devices is preferred.
• Proficiency in Microsoft Office Suite and Adobe Acrobat.
• Strong written and verbal communication skills, including communicating with non-English speakers.
• High attention to detail and accuracy.
• Ability to plan, prioritize, and manage multiple projects effectively.
• Desire to obtain Notary Public certification is a plus.

Experience in Regulatory Affairs is preferred.

For more information about this position, please contact: