Thank you for your interest in our services. Listed below are several open positions. Please contact us for additional information on current job openings or should you have any questions for us. We look forward to working with you and finding the best opportunity to meet your career needs.
Vice President of Regulatory Affairs
Reporting to the CEO, must be very hands-on and write submissions (IDE, 510(k), and letters to file). The company is a very high growth opportunity on a leading team. Please contact Adam Talmadge (email@example.com, x100).
Vice President of Clinical Affairs (Peninsula)
Biopharmaceutical company is looking for a rising star to take their neurological product and team to the next level. Please contact Adam Talmadge (firstname.lastname@example.org, x100).
Sr.CRA/CRA II (Peninsula)
The Sr. CRA is responsible for coordinating the monitoring and collection of high quality clinical research data from the sites and to ensure its proper transmittal to the data management group. This is a key clinical research position to coordinate the drug development programs in a phase III oncology trial. (5 available positions). Please contact Matt Talmadge (email@example.com, x102).
A growing in-vitro diagnostics (IVD) company is looking for a QA Manager well versed in deviation and CAPAís. This person must have a strong understanding of Quality Systems and the ability to handle QA issues internally. Please contact Matt Talmadge (firstname.lastname@example.org, x102).
Document Control/QA Specialist (Peninsula)
Novel biopharmaceutical startup company is looking for a Document Control/QA Specialist. This position will be responsible for processing boxes of unprocessed documents. Thereafter, the ideal candidate will manage the document control function while gaining additional QA experience as needed. Please contact Matt Talmadge (email@example.com, x102).
Technical Support Specialist (East Bay) An East Bay diagnostic company is looking for a Technical Support Specialist to provide technical support for the companyís Lablink QC program. This person will interface the customers via phone, fax, e-mail and respond to customer inquiries and complaints. A med-tech/clinical lab background is highly preferred. Basic chemistry and chemical reaction knowledge is required. Please contact Matt Talmadge (firstname.lastname@example.org, x102).
QA Specialist I-IV
A growing pharmaceutical company has three open QA Specialist positions at the I/II, II/III, III/IV levels. At the I/II level, the position requires experience in performing QA sampling and inspection activities for GMP incoming components, line clearance, and in process for GMP Manufacturing. At the II/III-III/IV levels, the candidates will review manufacturing batch records and analytical release testing data according to the SOPís to ensure cGMP compliance. This person will also participate and conduct internal and external audits. Knowledge of quality systems ensuring control of drug manufacturing facilities and processes in accordance with cGMP is necessary. Please contact Matt Talmadge (email@example.com, x102).
Complaint Specialist (several openings) (Peninsula) A growing medical device company is looking for a Complaint Handling Specialist/Complaince Specialist that can file MDRs, trend complaints, and follow up with customers, physicians, and/or clinics. This person must be trainable and can enter the position with only a few years of experience. Please contact Matt Talmadge (firstname.lastname@example.org, x102).
Vice President of Manufacturing
Medical device company is seeking a VP of Manufacturing who can run operations, materials and various departments. The challenge will be to take the company to the next stage and move from producing 400 units/month to 4,000/units/month in 2 years' time. Please see Adam Talmadge at 253-853-3707x100 (email@example.com).
Clinical Affairs Manager
A private diagnostic company is looking for a ClinicalManager to share responsibility for a broad spectrum of clinical activities including: pre-clinical and feasibility studies, FDA clinical trials and device submissions, clinical post marketing studies. Must have experience with FDA device submissions, at least 5 years clinical affairs experience in the medical device/biotech industry, and previous site monitoring experience. Travel is 20-25%. Salary from 80-100k. Contact Matt Talmadge at 253-853-3707 ex #102 (firstname.lastname@example.org).
Quality Engineer Growing pre-IPO Class 3 medical device company is looking for a ands-on Sr. QE or QA Manager with Quality Systems background incluing: receiving inspection, validation, CAPA, non-conformance, process validation. 80-105K. Please contact Matt Talmadge 253-853-3707x102 (email@example.com).
CRA positions (6)
Growing Class 3 medical device startup in the interventional cardiology field is looking for a CRA. The position is a growth opportunity for someone who wants to increase their exposure in Clinical Affairs. Please see Matt Talmadge 253-853-3707x102 (firstname.lastname@example.org).
Regulatory Affairs Manager (2)
2 separate medical device companies is looking for a Regulatory Affairs Manager who can write the company's 510(k)s. Ideal candidate is a Regulatory Affairs Associate or Specialist. Salary is 70-85K. (email@example.com).
Regulatory Affairs Specialist/Manager:
East Bay Medical Company looking for an experienced candidate with 2-10 years of experience in Regulatory Affairs and domestic and international registrations. Opportunity to learn from an experienced Director. Please call or email Matt Talmadge (253-853-3707x102, firstname.lastname@example.org).
Vice President of Regulatory Affairs, QA, and Clinicals
Looking for a seasoned Vice President of Regulatory Affairs with PMA experience and an advanced degree preferred. Relocation assistance available. Please contact Adam Talmadge 253-853-3707x100 (email@example.com).
Clinical Affairs Manager An exciting medical diagnostics company in the SF Bay Area seeks an experienced Clinical Affairs Manager to manage a clinical study. The company recently received three 510(k) approvals and is currently in pre-clinicals. The person will manage the new Clinical trial, monitor (10-15% travel), ensure data collection, oversee patient screening and enrollment, monitor compliance to study protocols, and review case report forms and data reports for accuracy. Salary is 90-120K (firstname.lastname@example.org).
Sr. Process/Manufacturing Engineer Class 3 medical device company on the Peninsula is looking for a hands-on senior process engineer in the design and development of various processes. Strong line support experience is highly desired (email@example.com).
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