• Serves as the Regulatory Affairs (RA) lead on global Market Expansion registrations for simple to medium complicated projects for initial product approvals and renewals, for assays, instruments or software, in global Eastern Europe regions outside the EU to ensure OTD product launches.
• Prepares the regulatory strategy and submissions and interacts cross-functionally to ensure OTD product registrations. Interacts with regulatory agencies/health authorities to resolve queries and to obtain and maintain product approvals globally.
• Serves as RA representative to gather and interpret new and changed regulations and guidelines.  Implements continuous improvements and efficiencies using DBS tools.
• Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information.
• Uses knowledge of regulations and develops regulatory strategy for introducing new products to global regions to meet business priorities.

The essential requirements of the job include:

• Bachelor's degree in field with 5+ years of related work experience OR Master's degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience
• Ability to work independently and maintain a "focused urgency" throughout the submission process.
• Strong written and communication skills, and comfortable to work in a dynamic multi-functional environment.
• Well versed in MS office and applications.

It would be a plus if you also possess previous experience in:

• Preference for familiarity with molecular science, or Polymerase Chain Reaction (PCR) based technology, or in diagnostics product development.
• Technical or operational related departments within an IVD or medical device industry is highly preferred.
• Regulatory knowledge and/or work experience with product submissions in regulated Commonwealth of Independent States and Balkan State countries.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

The salary range for this role is $103,000 - $160,000 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.