Regulatory Affairs Specialist

Company: Aerotek ( Learn More )

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General Information
US-UT-Salt Lake City
$70,000.00 - $87,000.00 /Year
Not Specified
Full-Time
Not Specified
Not Specified
False
False
Job Description Job Classification: Direct Hire The Regulatory Affairs Specialist is responsible for vigilant and continuous research of existing and new regulatory requirements that could impact company services and products. The Specialist will assist in the dissemination of this information to the appropriate individuals within the company. This position will be active in the development of policies, procedures and training aimed at ensuring regulatory compliance. Qualifications: Bachelor’s degree in a relevant scientific field. RAC Certification is a plus Five plus years experience with regulated products in the medical device industry Required Skills: Medical Device Excellent, reading, writing and communication skills. Orientation for detail work product, with emphasis or accuracy and completeness Ability to provide guidance to lower level personnel without alienation Ability to address complex problems and projects that involve ambiguity and rapid change with innovation and flexibility Ability to complete objectives without high levels of supervision. Proficient in basic office computer skills Excellent presentation skills Ability to work independently Solid understanding of manufacturing operations, change control, and awareness of regulatory trends Principal Job Duties and Responsibilities: 1. Performs all work in compliance with company policy and within the guidelines of Quality System. 2. Manages the company library of regulations, standards, and guidance documents required to ensure compliance of our product to domestic and international requirements.. 3. Maintain current knowledge of the developments and changes to applicable laws, regulations, standards, and guidance documents applicable to our industry, product, and Quality System. 4. Provide accurate and concise communication to senior managers on applicable topics and the potential business and product risks associated with compliance and/or non-compliance. 5. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, data, and trends. 6. Works with senior managers, and other groups as needed, to interpret regulatory requirements, and identify the best method for implementation within our existing systems to achieve compliance. 7. Assists with the development and maintenance of required regulatory Standard Operating Procedures and Work Instruction Documents. 8. Lead the development and implementation of regulatory education and training for applicable team members 9. Maintain regulatory registrations of product and business 10. Works with the Director of Regulated Products to research requirements for entry into new world-wide markets. Additional Responsibilities 1. Looking at/monitor all regulations that impact company 2. Read/interpret how the regulations impact the business. 3. Communicate/train senior management on regulations and assist in implementation of what they found (Research/Interpret/informing) 4. Write SOPs / developing regulatory department 5. Take on special projects 6. Assist in regulatory training 7. Assist in working with expansion into emerging markets (Brazil, Russia, etc) 8. Assist in FDA QSR, guidelines /directives & updating medical device library.

Join Aerotek, one of the leading providers of engineering and engineering support professionals in North America. Due to our growth, we''re constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it''s more than just your day-to-day responsibilities that can make or break a job. It''s the support you get. That''s the reason Aerotek offers a variety of benefits including medical, dental, optical, 401k, and many more. Don''t put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.

Job Requirements
  • REGULATORY AFFAIRS, BS Degree, MEDICAL DEVICE
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