Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Regulatory Affairs Specialist.
Job Description:
Job Title: Regulatory Affairs Specialist
Job Type: Contract
Job Location: Sunnyvale, CA
Work Schedule: On-site
Pay Rate: $60, Based on experience
Description:
- The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identifying applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, and maintaining regulatory filings and licenses.
Essential Job Duties:
- 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.
- Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File, , pre-submissions, Health Canada submissions with minimal supervision.
- 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.
Required Skills and Experience:
- 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.
About Maxonic:
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.
Interested in Applying?
Please apply with your most current resume. Feel free to contact Manish Rajput (/) for more details.
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