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Principal Regulatory Affairs Specialist Job
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| Employer Name: |
SpiderID: 2499155 |
| Location: Minneapolis/St Paul, Minnesota |
Date Posted: 10/1/2008 |
| Wage: $95 - $100 K |
Category: Medical/Health |
| Job Code: 368 |
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Job Description:
The successful candidate will have a broad knowledge of worldwide regulatory requirements and be able to provide hands-on regulatory services to the CV SBU. This position will be focused on the following key areas of responsibility:
Developing effective business/balanced regulatory assessments and strategies in support of new product initiatives, product line extensions and in support of long-term product portfolio planning
Advise development teams on regulatory requirements surrounding clinical evaluations and case studies used in support of modified devices and/or claims
Preparing regulatory submissions (510(k), PMA) to secure FDA marketing clearance.
Meeting and aligning with regulatory bodies in the early stages of NPD to ensure effective path to market
Preparing Technical Files and Design Dossiers in compliance with the European Medical Device Directives with interaction with Notified Bodies
Preparing / coordinate regulatory submissions for all areas of the world (Asia/Pacific, the Americas)
Educating the organization on the review, approval and regulatory aspects of product labeling and marketing literature
Monitoring changes to domestic and international regulations and standards and insuring compliance within the CV SBU to all applicable regulations and standards
Monitoring the competitive landscape and advising CV SBU on actions to be taken with regard to opportunities or threats.
Post-surveillance leadership specifically with regard to field correction activities
Internal and External audit leadership
Challenges will be balancing business regulatory compliance with company's competitive position, staying abreast of the ever-changing regulatory environment, broad yet deep knowledge requirements, and the ability to complete extensive day-to-day regulatory documentation.
Job Requirements:
Bachelor's degree (BS) in a science or technical arena (preferably engineering)
RAPS Regulatory Affairs Certification (RAC), preferred
Fifteen+ years overall experience in a regulated industry, required
Five-10 years in the Medical Device Industry
Five years experience in developing and leading regulatory submissions/ registrations/ technical files is required.
Strong working knowledge of QSRs and other applicable FDA regulations; specifically Design Controls, required.
One-3 years experience in conducting / monitoring clinical trials preferred.
Experience working in an FDA-regulated environment for software controlled electromechanical devices or sterile disposables, required
Experience with ISO9001, ISO 13485, CE marking requirements, and MDD required
Experience with General Principals of Software Validation and ISO14071, and Risk Management ISO14971, required
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Job Benefits:
Relocation Assistance
Contact Information:
| Contact Name: Ira Duesler |
Company Type: |
| Company: GRN Utica |
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| City: Clinton |
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| State: New York |
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| Zip: 13323 |
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Web Site: http://www.grnutica.com
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