Senior Regulatory Affairs Associate

Organization
Luminex Corporation
Job Location
Madison, WI 53717
Job Description

POSITION SUMMARY

The Senior Regulatory Affairs Associate has responsibilities relating to both pre and post market compliance with US and international medical device regulations.  The Senior Regulatory Affairs Associate assists with activities that support rapid entry into new markets upon development of new products and to maintain existing products. The Senior Regulatory Affairs Associate develops 510k, Pre-Submission and IDE submissions, and ensures timely regulatory filings and documentation processes including technical files.

ESSENTIAL JOB DUTIES

 Key Responsibilities of the Job:

  •  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 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
  • May assist with training and mentoring other RA associates and staff
  • Other duties as required

 

JOB REQUIREMENTS

 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, degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology is preferred 

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
  • 5 years of experience in a GMP and/or FDA regulated environment, medical device industry or equivalent.  Experience with in vitro medical devices preferred.
  • Experience working independently in a fast-paced environment with rapidly changing priorities
  • Experience as a Technician/Scientist or related biological discipline 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 at least 90% of the time
  •  Travel may be required approximately: 20% of the time
  • Work situations include dealing with people; working alone; making judgments and decisions 

Physical Requirements: 

  •  Lifting/Use of Strength is Sedentary (up to 10 pounds)
  • Climbing on the job is required:  Never--this job does not require the demand
  • Kneeling on the job is required: Never--this job does not require the demand
  • 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

 

Requirements

JOB REQUIREMENTS

 Required Education/Training: 

  • Bachelor’s Degree, degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology is preferred 

 

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
  • 5 years of experience in a GMP and/or FDA regulated environment, medical device industry or equivalent.  Experience with in vitro medical devices preferred.
  • Experience working independently in a fast-paced environment with rapidly changing priorities
  • Experience as a Technician/Scientist or related biological discipline 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 

Required Certifications/License/Special Skills: 

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 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 

 

 

About Our Organization

Luminex is committed to creating innovative, breakthrough solutions to help our customers improve health and advance science worldwide. We serve the needs of our customers in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, including genomic and proteomic research, personalized medicine, biodefense research and food safety. Our goal is to transform global healthcare and life science research through the development, manufacturing, and marketing of proprietary instruments and assays that deliver cost-effective, rapid results to clinicians and researchers.

Luminex Corporation enjoys an entrepreneurial fast-pace environment of highly motivated and creative individuals. At Luminex we have a passion for innovation and are dedicated to positively impacting the health, safety and quality of life for people around the world. Luminex Corporation features an excellent compensation and benefit plan.

Should you take the challenge to change lives, Luminex has this immediate opening where you can make a difference.

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