Manager of Regulatory Affairs - (US-AB-Calgary - T3Z 3W2)

Compensation: $80K - $110K / Year
Minimum Education: Bachelors
Job Type: Full Time
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eConsultAmerica is a preferred vendor supplier on retainer with a major global supplier of health products with the oldest, best known and most respected health products in the world. Our client is seeking an experienced and savvy Manager of Regulatory Affairs. This position will be based in Aliso Viejo, CA. Relocation Package is available and offered to highly qualified candidates. If you are interested please forward a brief cover-letter and your updated resume and I will respond back within one (1) business day. US Citizens or Green Card holders only apply.


Contact Information
eConsultAmerica
resumes@eConsultAmerica.com - Email
eConsultAmerica – Yahoo Instant Messenger
eConsultAmerica@skype.com – Skype Instant Messenger


Job Description

The chosen candidate will provide Regulatory Affairs support to manage product development projects to include 510(k), PMA, IDE, label/advertising review and other regulatory affairs support activities.


Job Duties

Prepare US and non-US product submissions such as 510(k), PMA, IDE, CE technical file. This requires participation in product development teams as well as to review, analyze and comment on technical reports. Provide comment and review to technical and clinical reports developed for Surgical products. . Review, approve and provide guidance for labeling and advertising of device products. . Provide review and guidance of failure investigations and corrective actions referred to Regulatory Affairs. Provide guidance on regulatory compliance issues. . Prepare, review and approve policies and procedures. . Interact with US and non-US government officials on product approval and compliance issues. . Provide input and comment to regulations and standards which may affect device products.


Qualifications
BA/BS degree in a technical or scientific discipline is required. Advanced degree or additional professional training would be of value.
7 years experience in Regulatory Affairs with an emphasis in Pharmaceuticals.
10+ years experience in the medical device or drug industry desired. Knowledge of medical device or drug GMPs desired.


Special Skills:
Candidate must have excellent communication, organization, and writing skills.
Specialized Training: Computer literate with general office software and internet use


Compensation
80K – 110K