• Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
• Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
• Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
• For CDx or Lifecycle Support areas have responsibility for creation and submissions of US FDA pre-submissions, 510(k)s andPMAs for assigned projects.
• For International area ensures overall compliance with international standards and directives. Responsible for activities which lead to and maintain international regulatory approval to market devices.
• May review, interpret, and report Regulatory leadership on product-specific regulatory issues that may have a material impact on the business units, the corporation, or the customer. May work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment.
• Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
• Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
• Manages the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs
• Provides regulatory support to project teams.
• Serves as Functional Lead on the project team(s).
• May provide consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues.
• May perform other duties as required or assigned.
• B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred.***** Regulatory Affairs Certification preferred.
• 3-5 Experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries.***** Regulatory Affairs experience is required. IVD device experience is preferred.
• Experience with Microsoft-based applications and general knowledge of PC functions necessary. ***
•Experience with regulatory submissions including IDE, 510(k), and PMA submissions is preferred.
• First experience for CDx with submissions for: IND, NDA/BLA or pharma exp. ***
•Strong organizational skills and attention to detail required.
•Excellent oral and written communication skills in English ****
Nice to Have:
• Advanced scientific degree a plus
• German skills written and oral
• Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus
•CDx specific experience in diagnostics or biomarker development with emphasis on oncology a plus
Job Title: Regulatory Affairs Manager
Location: Zug, Switzerland
Rate/Salary: 80.00 - 100.00 CHF Hourly
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.
To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.
We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield