Luminex Corporation: Regulatory Affairs Associate II, Madison, WI
Job Title: Regulatory Affairs Associate II
Company: Luminex Corporation
Location: Madison, WI
Job Type: Full-Time
The Luminex Corporation seeks a Regulatory Affairs Associate II for its Madison, WI office.
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
• Prepares and assists in 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
• Prepares and evaluates regulatory documents and company specific SOPs 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
• May assist with training and mentoring other RA associates and staff
• Other duties as required
Competencies:
• 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
Required Certifications/License/Special Skills:
• RA and/or CRA certification a plus
• Working knowledge of FDA submissions requirements and terminologies (Pre-Submission, 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:
• 3 years of industry experience in Regulatory Affairs, preparing and filing submissions such as 510(k), Pre-Submissions, IDE and maintaining regulatory documentation, registrations and device listings, both domestic and international
• Experience in a GMP and/or FDA regulated environment, medical device industry or equivalent
• Experience in medical device industry, in vitro medical devices preferred
• Experience as a Technician/Scientist or related biological discipline not required but considered an asset
• 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 approximately: 20% of the time
• 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:
• LLifting/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
• Stooping on the job is required
• 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.
