Job Description
Bill: $68.10
Pay: $48-45
Spread:298.2-445.6
Duration:~10-11 months
Manager: Philip Robledo
This Regulatory Affairs Device role will be based in Irvine, CA and works with internal and external partners in order to deliver products to patients.
Responsibilities:
Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision.
Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations.
Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class IIb (EU) medical devices.
Qualifications:
Experience supporting new device submissions, license renewals and variations (based on manufacturing site proposed changes) in countries outside of US, such as JAPAC (Singapore, Malaysia, Hong Kong, Vietnam), MEAR (S Africa, Botswana, and other African countries), LATAM (Brazil, Mexico).
In addition, there should be experience in responding to health authority questions satisfactorily due to submissions/renewals/variations.
May require an advanced degree and 3 to 5 years of direct experience in the field.
Recent experience with Class IIb (EU) medical devices;
Proven successful track record of authoring/submission/approval of Class IIb variations/renewals; knowledge of EU MDR 2017/745 regulation.
Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. A wide degree of creativity and latitude is expected.
Experience Level = 3-5 Years
Bussiness Unit:
R&D-Regulatory Affairs (RDRA)
Cost Allocation:
6003|CC|RDI RA GLO REG STRAT (601938)
Numbers & Facts
| Location | Irvine, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $45–$48 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Skills
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.
Free resume templatesFree resume builder
Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.
Free resume builder