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Vacancy details
Vacancy description:
Job Code:
2023528
Job Title:
Global Regulatory Affairs Manager Diagnostics
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Regulatory Affairs
Country:
Switzerland
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
12 May 2008
Description:
This position is the resident regulatory affairs authority for LSCA and the primary regulatory contact for business strategy development and product and process compliance regarding diagnostic (IVD) and medical product regulatory issues
The Regulatory Affairs Manager will be responsible for medical device regulatory compliance worldwide, including regulatory registration, notification and pre-market submission requirements, preparation and filing of regulatory documents with appropriate governmental regulatory agencies, and is the Chair of the LSCA Quality Council. This position reports to the VP/GM of the LSSU with a strong dotted line to the General Manager of the Diagnostics division.
Global Regulatory Affairs Manager Diagnostics
Analyzing the Life Science Future
The key responsibility is to identify the regulatory requirements needed to meet strategic and tactical business objectives of Research and Development, Quality, Order Fulfillment and Marketing Teams. You monitor, analyze, interpret and inform the organization regarding regulatory trends, relevant events and external meetings. This requires you to engage in appropriate activities with external bodies such as the FDA in order to understand and influence the regulatory environment.
Besides setting the strategic direction you direct the overall process of obtaining regulatory approvals for new products. This includes preparing and/or reviewing FDA and other agency submissions including 510(K), PMA, IDE, Technical Files, etc for all countries where Agilent markets IVD or medical products. You participate in FDA inspections, ISO 13485 audits and key IVD customer audits.
At a strategic level you participate in the product development processes to provide guidance in the selection of product targets and specifications to optimize the regulatory approval path. You provide guidance and advice on legal and regulatory issues and policies related to advertising, labeling, public disclosures, customer communication and Public Relations activities.
Qualifications:
To be successful in this position we expect you to have the following background:
• BS in Engineering, Chemistry, Biochemistry or related degree; MS preferred.
• Certificate in Regulatory Affairs preferred
• At least 10+ years of regulatory affairs experience with a device manufacturing company.
• Knowledge of QSR and IVDD requirements and GLP standards. Solid experience and proven track record in FDA successful submissions of 510K, IDE and PMAs
• Prior work experience at the FDA preferred
• Ability to travel up to 25%.
• Exhibited project management and leadership skills.
Personal Attributes Needed: This challenging positions requires the ability to analyze new regulations or policies and assess the impact on business processes and development programs and to implement change if needed. You bring excellent oral and written communication skills. The nature of the job requires you to be detail and quality oriented.
Location: Morges, Vaud
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Please Note: Applications to this vacancy are not made using our website. When you click above, you will be taken to the recruiter's website to complete your application.
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