Senior Regulatory Affairs Specialist - (US-CA-Hayward - 94557)

Minimum Education: Bachelors
Job Type: Full Time
Jobcode: 2854
Email this job to yourself or to a friend

Our client is a diagnostics company based in California, with their head office in New York. They offer products and services used by the industry to assist with the diagnosis, treatment and management of infectious diseases. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees.

Job Responsibilities:
1) Ensure compliance with FDA and other applicable regulations
2) Prepare, analyze and submit dossiers to various governing agencies for supporting business growth
3) Support applicable regulations, including ISO, local, state and/or federal requirements
4) Monitor proposed regulatory changes from the FDA, worldwide regulatory authorities and other regulatory agencies
5) Provide the management with impact of changes in the regulatory environment
6) Review related regulatory publications and documents to stay informed about current regulatory actions
7) Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission and submission discussions
8) Participate in training and education seminars (as appropriate) to learn regulatory requirements and demonstrate RA knowledge
9) Document, consolidate and maintain communications (oral and written) with FDA, notified bodies and clinical investigators
10) Assist with filing annual notifications, annual establishment (state and federal registrations) and product changes of FDA, Health Canada, EU, notified bodies, etc.
11) Compile and submit device experience reports as per FDA Medical Device Reporting System, EU Device Vigilance System, etc.
12) Support the design control process by providing regulatory review for design control binders
13) Ensure consistent application of law, regulation and guidance across design projects
14) Participate in and conduct internal audits
15) Interact with responsible departments to manage collection, reviewing and assembly of scientific, clinical, manufacturing and administrative sections of submissions to regulatory agencies
16) Participate in third party audits (e.g. FDA, State of California, Notified Body, etc.) of the quality management system
17) Assist in developing responses to support audit corrections and rebuttals
18) Participate in product recovery process and generate regulatory risk assessments for product issues with customer exposure
19) Maintain external references along with lists of national and international regulations, standards and FDA guidance documents that affect the products and operations
20) Assist with development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information
21) Review change control documents and ascertain the regulatory impact of external and internal documents

Job Requirements:
1) BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or a related discipline
2) 5 – 15 years of experience in a regulatory affairs environment for a medical device, pharmaceutical or biotech industry
3) Experience in working on a project/product (from concept to market introduction)
4) Experience in negotiating technical issues with internal and external functions, including health authorities
5) Knowledge of US and/or European/International regulations and standards
6) Expertise in preparing regulatory submissions on drug, device and biologic products preferred
7) In-depth understanding of manufacturing and change control as well as an awareness of regulatory trends
8) Experience in interacting with FDA staff and/or other regulatory agencies
9) Demonstrated success in securing regulatory approvals preferred
10) Ability to work independently and in a team environment with individuals from diverse functional areas
11) Superb leadership skills in a team setting
12) Excellent analytical abilities

Applicants are encouraged to apply directly by going to:http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02854.html

Salary: Experience Based