Job Description
Job Title: Regulatory Affairs Associate
Location: Santa Clara, CA 95054 (100% Onsite role)
Duration: 12 Months Contract to start with possible extension
Notes from hiring manager:
• They must have experience with change control, change orders and quality.
• Preferably they are not interns, need someone with more experience than an intern.
• Candidates who have experience with change control, change orders and quality.
• Manager is wanting local candidates only.
Description/Summary:
This role will provide support to the Regulatory Affairs organization by:
A. Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
B. Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance's are met.
C. Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance.
D. Driving quality system process improvement initiatives.
Initiatives include but are not limited to:
1. Establishing emerging issues in our quality system.
2. Maintaining the quality system procedures (e.g. change management).
3. Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements.
4. Troubleshooting with regulatory affiliates.
5. Participating in RA projects.
Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations.
Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
List of tasks:
• CFG requests in the FDA database.
• Declarations of conformity.
• Review Regulatory Letters and maintain LoA / PoA tracker.
• Will coordinate pan-franchise requests for multiple products, schedule meetings with international requesters.
• Maintain tracker / SharePoint / folders with current state.
• Change management.
Skills:
• Independent
• Troubleshooting
• Critical thinker
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously.
Other Responsibilities:
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• May require an advanced degree and 5-8 years of direct experience in the field.
• Recent experience with Class III implantable medical devices.
• Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements.
• Knowledge of FDA PMA guidance documents and CFR regulations.
• Relies on extensive experience and judgment to plan and accomplish goals.
• Performs a variety of tasks.
• May lead and direct the work of others.
• A wide degree of creativity and latitude is expected.
• Typically reports to a manager or head of a unit/department.
Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.
Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilitiesSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities
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