Manager Of Regulatory Affairs Jobs in Utah

Job Title: Regulatory Affairs Manager Company: MRINetwork Location: Salt Lake City, UT Description: Our client is a leader in their market space with impressive growth. They have a critical need for a regulatory affairs manager. This individual will be reporting directly to the CEO and will be very influential in helping to set regulatory strategy for the company. With the growth that the company experienced last year and the exciting new products that this person will help to bring to market, this is a great opportunity to be with a group whose products make a difference in the lives of their customers in a team environment where you can truly enjoy going to work every day. If this sounds like the opportunity for you, please reply promptly for immediate consideration. Minimum requirements: Minimum of 3 years experience in the regulatory approval process Authored multiple 510k's, PMA's, and IDE's Preference: Experience working with active implantable devices CE Mark experience Electrical engineering degree Our client offers: A fast paced, challenging work environment with opportunities for career growth Outstanding benefits including medical, dental and PTO for full time employees We regret that we cannot accept applications from candidates who do not possess all of the specified minimum requirements. For immediate consideration, please email your resume in Word format to Register to View

Job Title: Mgr, Regulatory Affairs Proprietary Operations Company: Watson Pharmaceuticals, Inc. Location: Salt Lake City, UT Description: Under general direction, responsible for compiling, submitting, maintaining and archiving all controlled correspondence, both paper and electronic, to/from all regulatory agencies (FDA, Health Canada, EMA, etc.). Determines electronic technical submission requirements to successfully file required regulatory documents. Keeps department informed of significant regulatory issues that affect submission requirements. Performs and/or manages subordinates in submission project planning and submission project management tasks.Essential functions: Carries out managerial responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Uses company provided software and equipment and/or manages subordinates to successfully generate regulatory agency compliant submissions. Serves as a resource to the Regulatory department regarding submission technical strategies and resolution of technical issues. Generates and maintains submission related project management plans and reports. Keeps management informed of submission related issues and status. Oversees, directs, coordinates and prioritizes the daily activities of assigned staff. Interacts with various departments as needed on regulatory submissions and other Regulatory Operations issues. Effectively communicates and implements determined processes, strategies, and tasks with the appropriate departments and/or employees. Interacts with regulatory agencies to determine the correct submission process of regulatory applications. Maintains awareness of all regulatory activities on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays. Interacts with outside consultants and or contractors as needed. Provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation. Ensures project deadlines and performance standards are established and met. Ensures compliance with all Company policies and procedures, including safety rules and regulations. Performs related duties as assigned. Qualifications Bachelors of Science Degree from an accredited college or university. Masters degree preferred, and Six (6) years relevant work experience or an equivalent combination of education and experience. Knowledge and Skill in: FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations. Principles and practices of budget preparation and administration. Pertinent Federal and State laws related to pharmaceutical regulatory affairs. Business, scientific and personal computer hardware and software applications. Business English usage, spelling, grammar and punctuation. Supervision and training practices and methods. Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods. Current Company policies, practices and procedures, including safety rules and regulations. Possesses understanding of the following areas: Regulatory environment; Document submissions; Submissions; Pharmaceutical & healthcare environment. Ability to identify routine procedures, regulations or regulatory guidelines that can be used to assist in issue and problem resolution. As part of Watson's mission, we dedicate ourselves to providing a respectful and rewarding work environment which includes competitive compensation and benefits. Watson Pharmaceuticals, Inc. values the benefits of diversity. EOE M/F/D/V As part of Watson's mission, we dedicate ourselves to providing a respectful and rewarding work environment which includes competitive compensation and benefits. Watson Pharmaceuticals, Inc. values the benefits of diversity. EOE M/F/D/V.