Regulatory Affairs Specialist Job at Randstad Life Sciences, San Jose, CA

ZDkyTmRtY0VSNE8vZG1nOTZXZ0puZmZ6
  • Randstad Life Sciences
  • San Jose, CA

Job Description

Job Description

Job Description

Regulatory Affairs Specialist

San Jose, CA - Hybrid (3 days on site / 2 days remote)

Pay: $40 - $50/hr based on experience

 

About this opportunity

The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatorystrategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance. This role requires strong organization, written and oral communication skills, and must be able to perform tasks with accuracy and a high attention to detail. Duration is 6 months with possible extension. This position will be based in San Jose, CA.

In this role, you will…

  • Perform regulatory assessments for product changes including regulatory reportability decisions
  • Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions
  • Support regulatory filing like a 510(k) or Pre-submission or a new/amended Health Canada License application for a Class II new product and may include renewal of Licenses
  • Support international regulatory filing
  • Assist in streamlining or updating regulatory processes Assist in regulatory intelligence activities
  • Assist in post-market surveillance activities, such as complaint handling and vigilance reporting Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance
  • Perform other related assignments as required

In this role, you’ll need …

  • Bachelor’s degree in Science, Engineering, Regulatory, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
  • Must be available to work with a hybrid schedule (3 days in office, 2 days remote) in office: San Jose, California
  • 1-2 years experience in medical device industry. Experience of medical device, SaMD development, or regulatory affairs is preferred
  • Knowledge of US regulations in medical device is required
  • In-depth knowledge and skills with computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint
  • Motivated and quick to learn new concepts and understand technical writing and medical device regulations
  • Proficient written and oral communication skills Organized and detail-oriented
  • Ability to manage work effectively in a remote capacity in a fast-paced, dynamic but often ambiguous workplace
Company Description

A great company doing groundbreaking and important work with a great reputation in the industry!

Company Description

A great company doing groundbreaking and important work with a great reputation in the industry!

Job Tags

For contractors, Remote job,

Similar Jobs

KARL STORZ Endoscopy - America

Operations Analyst II Job at KARL STORZ Endoscopy - America

 ...functional operations, project, and service level performance reports. The Operations...  ...similar analytical role) plus a bachelors degree; or 3 years relevant work experience plus...  ...analytics. ~ Bachelors degree in Mathematics, Economics, Information Management, Statistics,... 

Epic Travel Staffing

Travel OR Tech (Surgical Tech) Job at Epic Travel Staffing

 ...Job Description Epic Travel Staffing is hiring a Travel - Certified OR Tech / Surgical Tech (CST) Shift : Variable D/E / 6:45a, 8:30a, 2:30p, 8x5, 40hrs per week Length : 13 Weeks Requirements: ~2 years experience ~ Robotic, Vascular, and Orthopedic... 

Everest Clinical Research

Senior Clinical Data Manager Job at Everest Clinical Research

Everest Clinical Research ("Everest") is a full-service contract research organization...  ...strong foundation as a statistical and data management center of excellence. Building on this...  ...tracking and reporting. # Assist with study-level resource planning and management,... 

GHR Healthcare

Travel Nurse RN - OR - Operating Room - $1,455 per week Job at GHR Healthcare

 ...GHR Healthcare is seeking a travel nurse RN OR - Operating Room for a travel nursing job in Titusville, Florida. Job Description &...  ...Travel ~ Perks: 2 yrs experience required. Ratios 1:1. Every 3rd weekend. On-call required? Yes, Friday 3pm- 0630, Saturday 24hr call and... 

Novant Health

Registered Nurse (RN) - Renal Dialysis Job at Novant Health

 ...nation's 150 Best Places to Work in Healthcare by Becker's Hospital Review Recognized as Leaders in LGBTQ Healthcare Equality by the Human Rights Campaign One of the Best Places to Work for Disability Inclusion by Disability: IN and the American Association of People with...