About Emergo Group, Inc.
Emergo Group, Inc. is an ISO 9001:2008 registered medical device consulting firm that serves medical device companies, particularly those that export their products abroad. We ensure that our clients are consistently in compliance by offering comprehensive, customized Quality Assurance and Regulatory Affairs solutions for all major markets worldwide.
The majority of our client base is comprised of small to medium-sized medical device manufacturers that are required to develop, implement and/or maintain quality assurance systems and register their devices in order to export their products.
Our home office is based in Austin, Texas, with international offices in The Netherlands, Australia, Canada, Brazil, Mexico, Costa Rica, Egypt, Argentina, UK, France, Germany, Russia, India, Korea, Japan and China.
At Emergo Group, we are proud of our:
- Emphasis on total customer satisfaction
- Large and diverse domestic and international client base
- Integrity in dealing with customers, vendors, associates and the community
- High service standards
- Management team’s international background and experience
- ISO certification and regularly audited quality procedures
Our Regulatory Affairs department is currently looking for an individual with great writing, editing and communication skills to support regulatory affairs consultants. The position requires various duties including regulatory research, report writing and application preparation.
This position, based at our Austin, TX office, provides a great opportunity to build a long-term career within the organization and has potential to move the individual into a Global Regulatory Affairs Associate position in a fairly short time. Relocation is not offered for this position.
Specific activities include
- Assist in maintenance of document library in SharePoint.
- Assist in preparation of medical device registration applications, as well as various other applications.
- Perform regulatory research. This involves web searches, review of internal library, and other means.
- Write regulatory reports. This involves summarizing technical and regulatory information in a narrative form.
- Assist VP and Regulatory Specialists as needed.
We seek a candidate who possesses the following qualities
- Comfort with basic web technology
- 4 year degree or equivalent work experience is preferred
- Impeccable English writing skills required
- Excellent editing and communication skills
- Strong customer service and problem solving skills
- Ability to thrive in a fast-paced business environment, without the need for close supervision
- Strong attention to details and ability to follow procedures, processes, and instructions
- A quick learner – and motivated to excel in this position
- Ability to take direction and execute designated tasks
- At least 2 years full time employment experience preferred
- Fluency in English
- Fluency in a foreign language is a plus
- Good computer skills
Please email your resume and cover letter as Word attachments. Please also indicate your salary requirements.
Emergo Group, Inc. is an Equal Opportunity Employer.