Regulatory Affairs Manager Job in Calgary, AB - Adecco
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Job Summary
Regulatory Affairs Manager
Location: Calgary, AB Category: Information Technology
Status: Direct Hire Reference: ca_en_3_016563_8322
Posted: November 16,2016 Salary: N/A

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The Regulatory Affairs Manager job in Calgary, AB is a permanent position with our client. The successful candidate will have at least 5 years of previous experience in a Regulatory Affairs environment environment within the medical devices industry, knowledge of ISO 13485 standards, and experience working on domestic and international regulatory submissions for global market access.

Responsibilities of the Regulatory Affairs Manager job include:
- Preparation of technical documentation
- Maintenance of EU/Canadian/US regulatory certifications
- Support new product development, in conjunction with the product development team and sales/marketing staff
- Support product registration and the approval process within and outside of Canada
- Review and approve all changes regarding US FDA, European, and Canadian quality standards
- Maintain and improve the corporate quality standards
- Conduct site audits as required
- Other duties as required, including organization of management review meetings, and act as a contact person for appropriate regulatory bodies
- Prepare 510k or other required regualtory docuemntation as needed

Qualifications of the Regulatory Affairs Manager job include:
- Undergraduate degree from an accredited post-secondary institute (graduate degree preferred)
- Minimum of 5 years of related experience
- Knowledge and experience of QSR, MDD, and ISO 13485:2003 requirements
- Proficiency in Microsoft Office programs
- Exceptional interpersonal and customer service skills
- Professional, organized, and efficient

Qualified candidates interested in the Regulatory Affairs Manager job in Calgary, AB please apply online at www.roevin.ca or by direct email to Jeffrey Fischer at jfischer@roevin.ca

We thank all applicants however, due to volume, only those moving forward in the recruitment process will be contacted; your resume will be added to our database for consideration of future opportunities.

B5000



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**Note: Accommodation will be provided in all parts of the hiring process as required under Adecco’s Employment Accommodation policy. Applicants will need to make their needs known in advance to their Adecco representative.**