Senior Regulatory Affairs Specialist
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.
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
- 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
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.