Regulatory Affairs Specialist

Company: Innova Solutions
Location: Neenah
Posted on: May 28, 2023

Job Description:

Innova Solutions is immediately hiring for a Regulatory Affairs Specialist.Position type: Full-time (Contract) Duration: 12 Months Location: RemoteAs a Regulatory Affairs Specialist you will be:Participating and working independently on project teams developing/launching products by defining regulatory requirements and necessary regulatory deliverables to ensure compliance and successful achievement of business objectives.Actively participating in the Innovation management process by providing targeted feedback on proposed product designs to ensure potential regulatory hurdles are identified at the earliest stages of a project and appropriate business decisions can be made.Assessing regulatory pathway for new product platforms and product modifications; Develop regulatory strategies, regulatory summaries, assessments, and tactical plans to ensure compliance with FDA and Health Canada regulatory requirements.Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for U.S and Canada.Following by appropriate preventive communication and training within the company's business units.Providing consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances.Supporting product change management, complete product claims reviews, labelling/ingredient reviews to ensure regulatory compliance.Establish and maintain an information network for purposes of monitoring domestic and international regulatory developments, followed by appropriate preventive communication and training within the company's business units.Collaborating with Research and Engineer, Marketing, and legal teams in the development of compliant medical device labelling and product claims. Providing advice and counsel to staff and global manufacturing facilities regarding compliance with FDA, Health Canada Quality System requirements, as well as international and national standards, when necessary.Supporting the regulatory intelligence monitoring program by assessing changes in regulation and determining impact to medical device products.The ideal candidate will have:Proficiency in Regulatory experienceProficiency in FDA and Health Canada regulations.Experience in Medical Device / Consumer Products / Cosmetic ProductscQualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.Thank you!Arnab ShowTeam RecruitmentPAY RANGE AND BENEFITS:Pay Range*: *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)Clearly Rated Client Diamond Award Winner (2020)One of the Largest Certified MBE Companies in the NMSDC Network (2022)Advanced Tier Services partner with AWS and Gold with MSWebsite: https://www.innovasolutions.com/Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. * 1324b.The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.PDN-99213778-7173-40ea-94a1-55af468caf70

Keywords: Innova Solutions, Green Bay , Regulatory Affairs Specialist, Other , Neenah, Wisconsin