Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02838 About our client Our client is a leading medical device company specialized in ophthalmology and eye care products. They have over 13,000 employees globally and a reputation as a leading innovator in the field. With operations in 36 countries and a 150-year track record of success, this is a great situation for a candidate that is pursuing a challenging opportunity with a world-class employer. Position Location Director, Regulatory Affairs New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead RA Team to develop and execute regulatory submission strategies for a portfolio on a global, regional and country level 2) Train, develop and supervise the regulatory personnel who provide support to the business unit 3) Ensure that tactical objectives are achieved (US and non-US submissions, label and advertising review along with removals and corrections support) 4) Recommend and implement procedural improvements 5) Ensure timely regulatory clearances for new products 6) Maintain current knowledge and oversee the preparation of US and non-US submissions (IDE, 510Ks, PMA, PMA supplements, technical files, establishment registration and device listing) 7) Ensure that existing marketing authorizations are maintained 8) Lead and develop RA competencies (hiring, managing performance, creating and executing development plans for team as well as product skills development training) within the team 9) Challenge Project Team members and regulatory staff to seek alternate solutions and raise performance standards 10) Partner with key internal customers such as Marketing and R&D 11) Contribute to an environment that fosters collaboration, trust, regulatory and scientific excellence, creativity as well as proactive behavior 12) Provide inputs to global regulatory strategy development and implementation to achieve complete regulatory submissions in a timely and cost-effective manner 13) Review, approve and provide guidance for labeling and advertising of device products 14) Counsel technical and business groups to establish direction based on available data and regulatory considerations 15) Review as well as approve departmental policies and procedures 16) Interact with US and non-US government officials on compliance issues in a manner that establishes and maintains credibility to bring any issues to successful resolution 17) Provide guidance on regulatory compliance 18) Review and provide guidance on failure investigations and corrective actions referred to Regulatory Affairs 19) Provide inputs and comments regarding regulations and standards that may affect device products Requirements 1) BA/BS in a technical discipline like, Biology, Chemistry, Physiology, Engineering, Medicine or Law (advanced degree or additional professional training preferred) 2) 10+ years of regulatory affairs experience 3) Recent (within the last 3 years) experience in medical device/pharmaceutical industry 4) Experience in managing a team with the responsibility to hire/fire team members 5) Experience in managing people, driving process and managing projects 6) Ability to interact with internal and external constituents throughout the product lifecycle 7) Knowledge of medical device or drug GMPs 8) In-depth knowledge and skill in submission strategies as well as overall regulatory science 9) Experience in leading a team, performance management and talent processes 10) Ability to partner, negotiate and drive towards win/win outcomes 11) Ability to develop effective global internal/external relationships (e.g. cross category, cross-functional, etc.) 12) Excellent oral communication skills in English and technical writing skills 13) Ability to effectively present information in one-on-one and small group situations to internal customers and other employees 14) Ability to communicate well with all levels of the organization 15) Good questioning and problem-solving skills 16) Mathematical skills (commensurate with educational background) to describe and summarize laboratory and/or clinical data in product registration submissions 17) Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures 18) Ability to write routine reports and business correspondence 19) Proficient in computers (general office software and Internet use)
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