Description
The Regulatory Affairs Senior Specialist will serve as the RA lead on product lifecycle management project teams. This remote role involves completing regulatory reporting assessments for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies. You will have the opportunity to advise project teams on regulatory impacts, devise compliance strategies, and liaise with regulatory bodies during audits.
Company Culture and Environment
At Kelly, we prioritize diversity and inclusion at all levels, fostering a team that embraces a variety of backgrounds, communities, perspectives, and abilities. We believe that an inclusive environment enhances our ability to provide better services and solutions.
Career Growth and Development Opportunities
Kelly offers a range of professional development opportunities, including access to resources that can help you grow in your career. Our team is dedicated to enabling employees to reach their full potential in their chosen fields.
Detailed Benefits and Perks
Kelly provides eligible employees with a variety of voluntary benefit plans including:
• Medical, dental, and vision insurance
• Telemedicine
• Term and whole life insurance
• Accident and critical illness insurance
• Legal plan
• Short-term disability
• Access to a retirement savings plan
• Service bonus and holiday pay plans
• Transit spending accounts
• Paid sick leave under applicable state or local plans
Compensation and Benefits
• Pay range: (47/hr – )50/hr
• 1-year contract role
Why you should apply for this position today
This position offers a unique opportunity to engage with cross-functional teams and make a direct impact on product lifecycle management in a global setting. You will be part of a company that values your contributions while supporting your career growth.
Skills
• Understanding of Regulatory Affairs concepts and regulations/guidelines governing the development of IVD diagnostic products
• Knowledge of US-IVD, CE-IVDD, CE-IVDR governance for IVD diagnostic products
• Familiarity with QMS and ISO standards, including ISO 13485
• Problem-solving abilities with a continuous improvement mindset
• Strong communication skills to liaise effectively with diverse teams
Responsibilities
• Serve as the lead on product lifecycle management project teams
• Act as the lead for QMS/Compliance activities
• Collaborate cross-functionally to understand changes and impacts
• Identify project deliverables and contribute to developing schedules
• Ensure proper filing and organization of documents supporting regulatory assessments
• Work independently with minimal guidance and act as a resource for less experienced colleagues
• Review and approve change orders for anticipated changes
• Advise manufacturing, operations, and supply chain on regulatory impacts
Qualifications
• Bachelor’s degree with 5+ years of related work experience OR Master’s degree with 3+ years of related work experience
• Prior knowledge of Agile PLM system, SAP ERP system, and Salesforce-based applications preferred
• Experience in project management is a plus
Education Requirements
• Bachelor’s degree or Master’s degree in a relevant field
Education Requirements Credential Category
• Degree in a related field such as Regulatory Affairs, Life Sciences, or Engineering
Experience Requirements
• 5+ years of related work experience OR 3+ years with a Master’s degree in a related field
Why work in Sunnyvale, CA
Sunnyvale is known for its vibrant tech scene, offering a rich mix of innovation and opportunity. The city boasts a variety of dining options, outdoor activities, and a welcoming community, making it an ideal place for both personal and professional growth.
Location: Sunnyvale, CA, US
Salary: 47 – 50
Job Posting Language: en
Benefits:
- Health Insurance
- Dental Coverage
- Retirement Savings
Qualifications:
- Understanding of Regulatory Affairs concepts and regulations/guidelines governing the development of IVD diagnostic products
- Knowledge of US-IVD, CE-IVDD, CE-IVDR governance for IVD diagnostic products
- Familiarity with QMS and ISO standards, including ISO 13485
- Problem-solving abilities with a continuous improvement mindset
- Strong communication skills to liaise effectively with diverse teams
- Bachelor’s degree with 5+ years of related work experience OR Master’s degree with 3+ years of related work experience
- Bachelor’s degree or Master’s degree in a relevant field
- Degree in a related field such as Regulatory Affairs, Life Sciences, or Engineering
Responsibilities:
- The Regulatory Affairs Senior Specialist will serve as the RA lead on product lifecycle management project teams
- This remote role involves completing regulatory reporting assessments for anticipated manufacturing, facility, product, and packaging changes to global regulatory agencies
- You will have the opportunity to advise project teams on regulatory impacts, devise compliance strategies, and liaise with regulatory bodies during audits
- Act as the lead for QMS/Compliance activities
- Collaborate cross-functionally to understand changes and impacts
- Identify project deliverables and contribute to developing schedules
- Ensure proper filing and organization of documents supporting regulatory assessments
- Work independently with minimal guidance and act as a resource for less experienced colleagues
- Review and approve change orders for anticipated changes
- Advise manufacturing, operations, and supply chain on regulatory impacts
Benefits:
- Kelly offers a range of professional development opportunities, including access to resources that can help you grow in your career
- Kelly provides eligible employees with a variety of voluntary benefit plans including:
- Medical, dental, and vision insurance
- Telemedicine
- Term and whole life insurance
- Accident and critical illness insurance
- Legal plan
- Short-term disability
- Access to a retirement savings plan
- Service bonus and holiday pay plans
- Transit spending accounts
- Paid sick leave under applicable state or local plans
- Compensation and Benefits
- Pay range: (47/hr – )50/hr
- 1-year contract role
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