HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Companion Diagnostic Regulatory Affairs ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role, you will support establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in vitro diagnostics (IVDs)/companion diagnostics (CDxs).Key responsibilities:
- Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning and decision-making
- Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities
- Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development teams and joint project teams with diagnostic partners
- Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions (e.g. PMA, 510(k), IDE)
- In collaboration with diagnostic partners and internal teams, prepare for and conduct meetings with regulatory agencies.
- Review and approval of key diagnostic regulatory submissions to CDRH and global health authorities (as agreed with diagnostic partners) and corresponding therapeutic dossiers.
- Interacting with international regulatory colleagues and diagnostic partners to determine best practices and least burdensome regulatory paths toward development and global registration activities
- Assessing the impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development and registration activities, respectively
- Regulatory support of due diligence activities of external CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The versatile expert we are looking for plays a crucial role as a collaborative partner and possesses these credentials.Basic Qualifications:
Masters degree and 3 years of Health Agency or Med-Device or Regulatory experience
Bachelors degree and 5 years of Health Agency or Med-Device or Regulatory experience
Associates degree and 10 years of Health Agency or Med-Device or Regulatory experience
High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experiencePreferred Qualifications:
- MS Degree
- Degree in Regulatory Affairs, Life Sciences, or Engineering
- 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations
- 8 plus years of experience in medical device and/or IVD/CDx industry
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us!careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.