Senior Regulatory Affairs Specialist

Sunnyvale, CA

Posted: 10/29/2020 Position Categories: Science

Job Description

The Regulatory Affairs Specialist III will prepare the regulatory submissions to obtain and maintain product approvals with a focus on China and other international countries, as needed.

 

ESSENTIAL JOB RESPONSIBILITIES:

  • Draft, edit, and prepare regulatory filings in compliance with international regulations and guidelines
  • Responsible for meeting regulatory project timelines
  • Provide regulatory intelligence and keep abreast of changes in agency regulations and requirements.
  • Interact with global regulatory leaders and peers to expedite approval of pending registrations
  • Maintain collaborative relationships with external and internal customers – regulatory authorities, in-country affiliates, distributors and/or cross functional team members.
  • 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.

Job Requirements

Education and Experience (in years): 

  • Bachelor's degree in Life Science/Computer science or related 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

 

Knowledge and skills: 

  • Sound basis of Regulatory and /or Scientific knowledge
  • Ability to interpret subjective and complex aspects of specific regulations
  • Demonstrate in-depth understanding of advanced technical principles that relate to complex product lines or manufacturing processes
  • Must be detail oriented with well-developed organizational 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
  • Ability to work in a self-directed manner
  • 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

 

PREFERRED REQUIREMENTS:

  • Experience in Regulatory Affairs or related departments within an IVD and/or medical device industry is highly preferred
  • Experience in working with China regulatory authorities is highly preferred
  • RAC certification is preferred

Additional Information

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.

Richmar is an Equal Opportunity Employer.

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