Senior Regulatory Affairs Specialist

Job Title: Sr. Regulatory Affairs Specialist / Manager

Position Type: Full time

Location: Sunnyvale, California, United States

Team: Regulatory Affairs

Salary Range: 160k-165k

Job Description:

We are seeking a highly motivated and detail - Sr. Regulatory Affairs Specialist / Manager

Key Responsibilities:

• In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction.
• You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis, and implement and maintain an ISO 13485 and FDA compliant Quality Management System.
• Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities.
• Support government interactions pertaining to medical device registrations and licensing;
• Participate in the development of regional regulatory strategy and update strategy based on regulatory changes.
• FDA 510k and EUA application
• Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle.
• Support regulatory activities required for MDR compliance.
• Provide regulatory assessment for manufacturing and design changes.
• Provide regulatory review and approval of change order packets.
• Support product regulatory intelligence and risk assessments.
• Assist in maintaining compliance with product post market requirements.
• Support post-market regulatory actions taken for the products.
• Assist in the review of advertising and promotional materials.
• Support internal and external audits;
• Ensure compliance with internal procedures and external regulations and standards.
• Maintain and update quality system procedures.
• Maintain quality records and other controlled documents.
• Other Regulatory and Quality duties as assigned.

Qualifications:

• Bachelor’s degree in Science, Engineering, Math, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
• A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks.
• Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus.
• Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
• Can be independently responsible for 510(k) submissions

Compensation & Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Collaborative and inclusive work environment.
• 401K

About Us:

Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU.

IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com/.