Luminex Corporation: Regulatory Affairs Associate, Madison, WI
Job Title: Regulatory Affairs Associate
Company: Luminex Corporation
Location: Madison, WI
Job Type: Full-Time
The Luminex Corporation in Madison, WI seeks a Regulatory Affairs Associate to assist with development, management and implementation of regulatory strategies to support rapid entry into new markets upon development of new products and to maintain existing products. The Regulatory Affairs Associate develops US FDA, Health Canada and EU regulatory submissions and ensures timely regulatory filings and documentation processes including technical files.
Responsibilities:
• Prepare 510(k)s, letters/justifications to file, Investigational Device Exemption (IDE), Pre-Market Approval (PMA) Applications, PMA supplements and annual reports for both IDE and PMA as needed for Class I, II and III medical devices
• Assist as needed in preparation, review and submission of international regulatory submissions, product registrations and technical dossiers to Notified Bodies and Health Canada
• Prepare appropriate documentation for product CE mark certification
• Maintain regulatory documentation, registrations and device listings for both domestic and outside the US (OUS). Maintain international regulatory submission technical files, registrations/licenses, device listings and design dossiers for CE marking, and those required for Canada and other international countries outside the US.
• Interacts effectively with functional business units in order to facilitate documentation requirements for submissions, ensuring that departmental timelines are met. Communicate and coordinate regulatory activities with other departments
• Assists in preparation and evaluation of regulatory documents and company specific SOP’s to maintain FDA QSR & ISO 13485 compliance
• Provide appropriate regulatory guidance to research and operations staff
• Review and provide input to device labeling and advertising materials for compliance with FDA submissions and applicable regulations
• Review of product and manufacturing changes and compliance with applicable regulations
• Review of protocols and reports to support regulatory submission and product changes
• Participates on interdepartmental teams where required, including design control, FMEA, design and process validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files
• Participate in compliance activities that relate to the department and the company as a whole
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies
• Write/revise departmental SOPs as required
• Other duties as required
Requirements:
• Learning on the Fly–learns quickly/open to change
• Organizational Agility–knows how to go through the proper channels to get things done
• Peer Relationship–cooperative, team player, trusted and supported by peers
• Planning–sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps
• Priority Setting–focuses on what is most important
• Written and Oral Communications–effectively communicates verbally and in writing
Required Education/Training:
• Bachelor’s Degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology
• 3+ years of industry experience in Regulatory Affairs or Quality Assurance Systems within in medical device industry, in vitro medical devices preferred
• RA and/or CRA certification a plus
Required Certifications/License/Special Skills:
• General knowledge of FDA submissions requirements and terminologies (Pre-IDE’s, IDEs, 510k and PMA)
• Excellent organizational and project management skills with strong attention to detail
• Independent and self-directed individual
• Successful experience working with cross-functional teams
• Effective written and verbal communication and technical writing skills
• Strong skills and knowledge of corporate software tools — Microsoft Office Suite including Word, Excel, Power Point.
Required Work Experience:
• Experience working independently in a fast-paced environment with rapidly changing priorities
• Experience as a Technician/Scientist or related biological discipline not required but considered an asset
• Experience in a GMP and/or FDA regulated environment, medical device industry or equivalent
• Experience working independently in a fast-paced environment with rapidly changing priorities
• Multi-task oriented and organized to work within numerous systems and functions
• Work cooperatively in a team environment
Working Conditions:
• Must work onsite at Luminex office
• Travel may be required
• Work situations include dealing with people; working alone; making judgments and decisions
• Limited travel (up to 15-20% of the time, or as circumstances dictate)
Physical Requirements:
• Lifting/Use of Strength is Sedentary (up to 10 pounds)
• Climbing on the job is required: Kneeling on the job is required
• Reaching on the job is required: Never — This job does not require the demand
• Stooping on the job is required: Never — This job does not require the demand
• Vision (Color) on the job is required: Occasionally — up to 33% of the time
To apply online, please click here.
An equal opportunity employer, M/F/D/V.
Please reference BioTechPharmJobs.com when responding.
