Regulatory Specialist II

2 weeks ago

Santa Clara, United States Actalent Full time

Job Title: Regulatory Specialist IIJob Description

We are seeking a Regulatory Specialist II with 2-5 years of regulatory experience and/or 2 years of relevant industrial experience, typically within a quality product-development/support or scientific affairs function. The ideal candidate will have a strong understanding of regulations and standards affecting in vitro diagnostics (IVDs) and/or biologics. A BS degree in a technical discipline such as biology, chemistry, microbiology, immunology, or medical technology is preferred.

Responsibilities

  • Implement and maintain the effectiveness of the quality system.

  • Support manufacturing/operations day-to-day activities for change control.

  • Provide consultation and advice to regulatory specialists for change control and product development.

  • Provide regulatory direction and interpretation on team activities.

  • Interpret and apply regulatory understanding to support products and teams.

  • Prepare U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.

  • Handle regulatory activities involved in documentation, labeling, and field support.

  • Apply regulatory and technical knowledge to a wide variety of complex work assignments.

  • Maintain and ensure compliance with the appropriate quality system for specific medical devices designed or manufactured.

  • Ensure compliance with and demonstrate knowledge of site and division-level policies and procedures.

Essential Skills

  • 2 years of regulatory experience, preferably with medical devices.

  • Knowledge of regulations and standards for medical devices.

  • Strong understanding of quality systems.

  • Experience in preparing U.S. and EU regulatory submissions and/or registration documents.

Additional Skills & Qualifications

  • BS degree preferred in a technical discipline like biology, chemistry, microbiology, immunology, or medical technology.

Work Environment

The role involves supporting manufacturing and operations in a dynamic and regulated environment. The Regulatory Specialist II will interact with various teams to provide regulatory guidance and ensure compliance with quality systems and regulatory requirements. The position requires attention to detail and the ability to handle complex regulatory work assignments. The work environment is collaborative, and adherence to site and division-level policies and procedures is essential.

Pay and Benefits

The pay range for this position is $30.00 - $41.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision

  • Critical Illness, Accident, and Hospital

  • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available

  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)

  • Short and long-term disability

  • Health Spending Account (HSA)

  • Transportation benefits

  • Employee Assistance Program

  • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Santa Clara,CA.

Application Deadline

This position will be accepting applications until Dec 21, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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