Current Job Openings
Location: San Diego
Role: Regulatory Affairs Specialist II
Our client, a global medical company that develops, manufactures, and markets lifesaving plasma-derived medicine and diagnostic products is seeking to add a Regulatory Affairs Specialist II to their experienced regulatory affairs department at their fantastic facility in San Diego. In this role, you will support the domestic and international regulatory activities associated with FDA, Notified Body in EU, and other international regulatory agencies.
Key Responsibilities:
- Prepare, gather, and publish electronic pre-market and post-market regulatory submissions for FDA including IND, BLA, Prior Approval Supplement, CBE/CBE-30 supplement, annual Report and Type B/C Meeting Requests.
- Collect Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark.
- Interact with business partners to support ROW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.).
- Interact with FDA, write responses to information requests, compile complete response letters.
- Support the preparation of 510(k), PMA and PMA Supplement submissions for FDA (CDRH).
- Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis.
- Review of product labeling, literature and Web site for accuracy, consistency, and regulatory compliance.
- Develop and/or revise regulatory procedures.
- Provide regulatory support to existing and new cross-functional product core teams.
- Review new product design protocols related to verification and validation, risk assessment, etc.
Qualifications:
- Bachelor's Degree required in the life sciences or engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.
- Demonstrated ability to coordinate complex projects.
- Strong oral and written communication and presentation skills
- Solid working knowledge of the US Regulations and European IVD and medical device directives
- Good analytical and problem solving skills.
- Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
- Experience with (US) Biologics and IVDs highly desirable.
Established in 1995, PTS Advance provides people and tools to companies that want to do more than just "fill a position". Our expertise includes attracting and retaining key talent, while managing assignments in a safe, compliant, and transparent manner. We are honest and transparent in the process because we put you first.
Interested? Contact Christopher Mercedes at 949-268-4087 or via email at Christopher.Mercedes@PTSadvance.com for a confidential discussion.
