Regulatory Affairs Manager Combination Products
Regulatory Affairs Manager Combination Products
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$ 143224 - 143224
1 Vacancy
Job Description
Career Category
RegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION
Youve earned your degree. How will you use that achievement to reach your goals Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Regulatory Affairs Manager Combination Products
What you will do
Lets do this. Lets change the world. In this vital role you will support development and of regulatory strategies and filings for new and existing drug delivery devices and combination products establishing sustainable processes assuring informed relationships and delivering strategic outcomes.
- Support the development communication implementation and maintenance of regulatory strategic plans
- Lead and/or support health agency engagements
- Lead and/or support filing activities and associated health agency inquiries
- Support device design controls activities and documentation reviews
- Assess devicerelated standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions
- Perform change control regulatory assessments
- Develop and support implementation and maintenance of internal regulatory processes
- Perform device determination decisions for regulated items
- Support supplier engagement teams and due diligence activities
- Review regulatory sections in development quality and supply agreements
- Support regulatory compliance initiatives
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications.
Basic Qualifications:
- Doctorate degree OR
- Masters degree and 3 years of pharma/biotech and/or medical device and combination products regulatory affairs experience
- OR
- Bachelors degree and 8 years of pharma/biotech and/or medical device and combination products regulatory affairs experience; OR
- Associates degree and 10 years of pharma/biotech and/or medical device and combination products regulatory affairs experience; OR
- High school diploma / GED and 12 years of pharma/biotech and/or medical device and combination products regulatory affairs experience;
Preferred Qualifications:
- Masters degree in regulatory affairs engineering or life sciences
- 6 or more years of experience in medical device and combination products regulatory affairs
- Experience in design controls manufacturing process development quality assurance quality control or analytical development
- Experience in drug delivery device or diagnostics device regulatory submission process
- Regulatory CMC specific knowledge and experience
- Mature project management and organizational skills
- Strong and effective oral and written communication skills
- Experience in Veeva Vault platforms
Thrive
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 wellbeing.
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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and biannual companywide shutdowns
- Flexible work models including remote work arrangements where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position
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.
.Salary Range
112345.00 USD 143224.00 USDRequired Experience:
Manager
Employment Type
Full-Time
