Senior Regulatory Affairs Manager

Santa Rosa, CA 95403

Posted: 02/08/2017 Employment Type: Direct Hire Job Number: 2418

Senior Regulatory Affairs Manager

This is a critically important role leading a team of Regulatory Affairs (RA) professionals working on the current and future portfolios of coronary drug eluting stents.  By working with cross functional teams, this manager must develop and implement regulatory strategies to obtain timely product approvals from worldwide regulatory bodies.  This position involves working in partnership with global RA colleagues to ensure regulatory submissions are accurately prepared and comply with global regulations.  This manager must provide proactive and constructive input in support of company goals, objectives, policies, and procedures.  The individual has a track-record of building strong teams and developing innovative regulatory strategies for novel, Class III products. Global combination device experience would be beneficial.  
•  Oversee the development and implementation of global regulatory strategy in conjunction with global RA staff
•  Manage FDA and notified body relationships directly and through the Coronary RA team
•  Ensure the timely and accurate filing of all regulatory documentation
•  Ensure compliance with Quality System Regulations and associated requirements  
•  Manage systems and programs in support of corporate goals and objectives
•  Represent CRDN RA as a member of site, business, or corporate process improvement initiatives
•  Establish and maintain a professional relationship built on mutual respect with key physicians, consultants, vendors, co-workers, and regulatory agencies
•  Recruit, hire, train, manage, and develop regulatory affairs staff members
•  Actively promote team building and maintain positive morale within the department
•  Stay current with respect to competitive technologies and associated regulatory strategies
•  Regularly make presentations to senior staff members
•  Procure and oversee outside vendors and consultants as required
•  Perform other duties as assigned


Bachelors Degree with 8+ years of regulatory affairs experience or experience in a related field and 3+ years of supervisory experience

Desired Qualifications: 
•  Demonstrated practical experience working directly with regulatory agencies, preferably including both FDA and European notified bodies
•  Experience working on global regulatory submissions for combination products 
•  Good working knowledge of clinical trial design and data analysis
•  Demonstrated knowledge of global medical device regulations & overall regulatory environment 
•  Track-record of improving regulatory or cross-functional business systems and processes
•  Demonstrated supervisory and interpersonal skills

Thorough working knowledge of word processing, spreadsheet, and presentation applications (Microsoft Office, Adobe Acrobat). Organizational skills, attention to detail, and effective project management skills.

Flexible with changing priorities, self-motivated, strong work ethic, works well under pressure and thrives in a dynamic environment. Tactful, exercises independent judgment and discretion, professional presentation, advanced communications skills (written and oral), team player.
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