RA/QA Manager II (Regulatory Affair Manager) 8/17/2016
JOB DESCRIPTIONJob Description
Is your passion in Medical Device Regulatory Management* Are you looking to continue your already illustrious career in a global, family-owned life sciences company* Then we have the role for you!
Bio-Rad Laboratories is currently looking for a Regulatory Affairs Manager to head up the development, coordination and implementation of regulatory strategies for new products and marketed product registration, as well as licensing opportunities. This position will focus more on the regulatory aspect of registration and approval of biological materials, as opposed to quality assurance.
What you ll be doing:
* You ll be accountable for the Life Science Group s global regulatory strategy plan for their products and defend the plan with Regulatory Affairs Leadership.
* Take responsibility for ensuring timely development for regulatory strategy and operating plans.
* Regularly report to management on progress against objectives and plans.
* Plan and direct projects and provide technical background, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team.
* Lead the team in planning, preparation, and execution for meeting global product regulations (e.g., CFDA, REACH, RoHS, USDA, FDA).
What you ll need for this role:
* Bachelor's degree in scientific field or equivalent combination of education and related work experience; master's degree preferred.
* 5-8 years (or equivalent combination of education and related work experience) of life science and drug discovery industry and experience in new regulated product strategy and submissions; including working knowledge of FDA and Health Canada laws / regulations / guidance applicable to registration and approval of drugs or biologics.
* Practical experience in submitting 510Ks.
* Availability to travel up to 5% globally and 10% domestically.
What s in it for you:
* Competitive pay and great benefits including medical, dental, vision, 401k and more
* Opportunities for growth and training
* Stability of a profitable 60+ year old company
* Great work environment
This position is located in our Headquarters in Hercules.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
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To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.