Manager, International Regulatory Affairs

Cepheid Sunnyvale , CA 94085

Posted 2 weeks ago

MANAGER, International Regulatory Affairs

The Manager, International Regulatory Affairs will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on Africa, S.E. Europe, Middle East and surrounding countries. Assist with ROW submissions as required.

Responsibilities:

  • Responsible for regulatory project timelines and management of global regulatory submissions.

  • Lead regulatory activities including planning and reviewing of regulatory submissions.

  • Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines.

  • Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives

  • Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements

  • Interact with global regulatory leaders and peers to expedite approval of pending registrations

  • Interact with departments to generate protocols and reports that require in-country testing data for registration purposes

  • Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.

  • Support RA functional area in the review and approval of Change Orders.

  • Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed.

  • Maintain a "focused urgency" as required by specific events

  • Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors

  • Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions

  • Assess potential impact and/or applicability to other related areas

  • Assess corrective action to assure it prevents recurrence

  • Provide regulatory training to cross-functional groups

Required Knowledge Skills and Abilities:

  • Bachelor's degree in a Life Science or related field preferred with 9 years experience. Or, equivalent combination of education and experience to perform at this level

  • A minimum of 5-6 years of experience in regulatory/Quality or related departments within an IVD or medical device industry

  • A minimum of 3-5 years management experience with atleast 2-3 direct reports

  • Must be detail oriented with well-developed organizational and analytical skills

  • Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat

  • Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment

  • Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes

  • Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations

  • Able to confidently deal with ambiguous issues and provide input towards suitable actions

  • Strong oral and written communication and presentation skills

  • Effective communicator of technical & non-technical information

  • Ability to work in a self-directed manner to see issues through to completion

  • IVD product experience is highly preferred

#LI-LW1


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Manager, International Regulatory Affairs

Cepheid