Abbott is seeking a Principal Regulatory Affairs Specialist to work on-site in Alameda, CA. The role will involve leading global regulatory submissions, developing innovative regulatory submission strategies, and providing executive management with regulatory metrics/information. The ideal candidate will have experience in US/EU/global submissions and on-market changes, and will be recognized as an expert resource both within Abbott and externally.
Requirements
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for In Vitro Diagnostic Devices and/or Medical Devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Device Regulation (2017/745) and/or the In Vitro Diagnostic Regulation (IVDR 2017/746).
- 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs.
- Regulatory Affairs Certification (RAC) is a plus.
- Experience with either 510(k) applications, PMA supplements, US Device Regulations, or with EU and other International Medical Device Regulations and Submissions.
- Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH guidelines.
- Experience with word processing, spreadsheet and presentation graphic software packages.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Ability to identify, solve problems, and work independently with little oversight.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes, and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail
Benefits
- Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
- Excellent retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit
- Diverse opportunities with a company that can help you build your future and live your best life
- Medical, dental, and vision benefits
- Life insurance
- Disability insurance
- Retirement savings plan
- Flexible spending accounts
