US-CA-San Diego-Associate Director, Regulatory Affairs
Status: Employee
Reference Code:RA 904526

Associate Director of Regulatory Affairs needed to manage all aspects of CMC regulatory dossiers in support of manufacturing, chemistry or controls changes to marketed products.
Key responsibilities include but are not limited to:
Provide CMC regulatory affairs strategy to ensure most expeditious approval pathway for manufacturing changes, such as new suppliers of ingredients or manufacturing site changes to marketed products.
Planning, writing, and coordinating the preparation of the CMC regulatory dossiers in a cross-functional team setting according to strict timelines and with attention to optimal quality.
Providing CMC regulatory expertise to the Manufacturing group and all cross-functional project teams with regard to CMC regulations pertaining to development of pharmaceutical drug products for U.S. registration.
Advise on additional CMC requirements for transitioning from Phase 2 to Phase 3 compounds and ultimate commercialization.
Preparation of Annual Reports for the NDAs of marketed products.
Leading the planning, coordinating and executing of essential milestone meetings such as End of Phase 2 and teleconferences with FDA CDER & CDRH on CMC related topics.
Writing CMC conformance guides for all of our marketed products, including expiration dating, approved manufacturing processes and suppliers of ingredients, container closure systems and stability programs.
Authoring and approving SOPs related to CMC topics and change control documents as necessary.

Position requires a PhD or MS in Chemistry, 5-10 years of pharmaceutical experience in an industry setting in the area of Chemistry, Manufacturing and Controls (CMC) in a regulatory capacity.
Experience preparing CMC supplements for approved NDAs as well as preparing CMC sections in NDAs BLAs PMAs, 510k's and INDs. Successful track record of approvals and success in negotiating the most expeditious approval times.
Experience with all phases of clinical development and a thorough understanding of the differing CMC requirements thereof.
Must have strong familiarity with cGMP requirements, all guidance documents and federal regulations related to CMC requirements.
Also, must have strong leadership and collaboration skills.

For consideration: meddevice@westcoaststaffing.com

US-Austin TX-Regulatory Affairs Manager-Medical Device
Status: Employee
Reference Code:RA 904527

Regulatory Affairs Manager

The person will be responsible for supporting regulatory submissions worldwide and marketing efforts. The areas of focus are expected to include spinal fusion, minimally invasive surgery and motion preservation technologies. This position will report to the DVP, Clinical and Regulatory. The successful candidate will demonstrate an ability to work successfully as an individual as well as within a team structure. The position will be responsible for leading the regulatory affairs function and providing regulatory affairs input to product development teams and management.

Responsibilities: The general responsibilities include:

Domestic and International regulatory submissions including 510(k) clearances and IDE’s in the U.S., and device licenses in Canada, Australia, Europe and Japan.
Regulatory responsibility on product development teams.
Regulatory signature authority.
Regulatory review of discrepant materials.
Labeling review.
Maintain current FDA registrations and listings.
Participate on a team to support regulatory submissions to domestic and international governmental bodies.
Other responsibilities, consistent with clinical and regulatory affairs, may be assigned as needed by the department.
Participating in process improvement teams to strengthen design control and product action procedures
Manage Regulatory department personnel.

For consideration: meddevice@westcoaststaffing.com

US-CA-San Diego Sr. Regulatory Affairs Specialist
Status: Employee
Reference Code:RA 904528

DUTIES & RESPONSIBILITIES

• Develops regulatory strategy and develops and maintains domestic submissions.
• Assists in the development and maintenance of international regulatory submissions.
• Participates in corporate assessments, to review corporate quality systems and provide feedback on the effectiveness of those systems.
• Reviews protocols for Simulated User Trials and Customer Preference Trials for compliance to the submission strategy.
• Reviews domestic and international labeling for compliance to labeling requirements, including content, format, 510(k) impact, etc.
• Provides regulatory/labeling support for International CE product marking and regulatory submissions.
• Reviews medical/scientific literature to support 510(k), labeling, and clinical strategy.
• Reviews Corrective Action Request forms for completeness and accuracy, publishes reports and follows up on issues.
• Coordinates recall activities. Develops and maintains tracking information for product recalls.
• Responsible lead for Device Listings and Facility Registrations (State & Federal), and official correspondent with the FDA.
• Responsible Regulatory lead for Review & Approval of Post Release NCMR's.
• Responsible regulatory lead for contract review.
• Provides regulatory information for Quarterly Finance Report.
• Provides regulatory guidance as needed.

• Bachelors degree and minimum of 3-5 years related professional experience; equivalent combination of education and experience.
• Knowledge of current FDA regulatory requirements and trends for medical device premarket notifications. Knowledge of instruments and disposable design practices. Knowledge of ISO requirements.

For consideration: meddevice@westcoaststaffing.com