Regulatory Affairs Specialist 4

Our Client, an American Biotechnology company, is looking for a Regulatory Affairs Specialist 4 for their Sunnyvale, CA/Hybrid location.


Responsibilities:

• Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
• Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets.
• Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies.
• Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
• Provide risk-based guidance and regulatory input to projects and issues, ensuring cross- functional alignment and resolution.
• Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.

• Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science)
• In-depth understanding of US Medical Device regulations, Health Canada guidance and EU MDR.
• Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement
• Ability to work in a fast-paced environment and handle multiple projects simultaneously
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within the regulatory landscape.
• Required Education and Training
• Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical
• Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable.
• Preferred Skills and Experience
• RAPS Regulatory Affairs Certification (RAC) is a plus.

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities