Regulatory Affairs Senior Manager - In-vitro Diagnostics - Thousand Oaks, CA | Biospace
Get Our FREE Industry eNewsletter

Regulatory Affairs Senior Manager - In-vitro Diagnostics

Amgen

Apply
Location:
Thousand Oaks, CA
Posted Date:
12/8/2016
Position Type:
Full time
Job Code:
R-27338
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Senior Manager will establish sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement In Vitro (IVD) regulatory strategies and processes for IVDs as well as medical devices (e.g., drug delivery devices, software) and combination products.

Key Activities:

Develop, implement, communicate, and maintain global regulatory strategies and plans

Manage or support IDE submissions for IVD or for Companion Diagnostics

Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission

Review and approve device design control deliverables, as applicable per internal policies and procedures

Review standards and guidance for applicability; assist in establishing Amgen regulatory positions and communicating these to relevant stakeholders

Perform change management assessments; determine and communicate post-approval reporting requirements

Develop and support implementation and maintenance of regulatory processes

Lead and perform internal policy reviews for global regulatory guidance and regulations

Contribute to and participate in internal and external education and training activities

Identify and communicate relevant guidance, policies, standards, and regulations

Build and maintain effective relationships with internal and external stakeholders

Additional Activities:

Support supplier engagement teams and perform external due diligence regulatory activities

Advise on labeling requirements and perform regulatory review of labeling

Perform determination decisions for regulated items

Review regulatory sections in development, quality, and supply agreements

Support regulatory compliance initiatives

Recruit, hire, supervise and mentor regulatory staff

Represent Amgen at external events (e.g., PhRMA, PDA, BIO, DIA, AAMI, ISO), as appropriate

Requirements

Basic Qualifications

Doctorate degree and 2 years of Regulatory experience

OR

Master's degree and 6 years of Regulatory experience

OR

Bachelor's degree and 8 years of Regulatory experience

OR

Associate's degree and 10 years of Regulatory experience

OR

High school diploma / GED and 12 years of Regulatory experience

Preferred Qualifications

Degree in Regulatory Affairs, Life Sciences, Engineering

6+ years of experience in Regulatory Affairs, including United States and international in vitro diagnostic regulations including medical device and/or combination product regulations

8+ years of related experience in in vitro diagnostic regulations including medical device or combination product industry

2+ years of direct managerial and/or leadership experience

Change implementation

Leadership

Learning

Negotiation

Oral and written communication

Planning and organization

Prioritization

Problem-solving

Risk assessment

Strategic thinking

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

HJUS2016

#LI-POST