Senior Regulatory Affairs Quality Systems Specialist

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products.  We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis.  We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

Responsible for supporting Meridian’s regulatory and quality system processes, specifically as it relates to the product realization process for SD Biosensor products to ensure that activities are consistent with applicable quality and regulatory requirements, especially the design, development and manufacture of in vitro diagnostic (IVD) medical devices.Primary responsibility will be acting as an advocate for Meridian’s project teams and contractors that are working directly with SD Biosensor – the primary goal of these projects is to bring regulated IVD products that are manufactured by SD Biosensor into the United States for review by the US FDA.Assist Meridian teams and contractors with communicating expected and compliant US FDA quality system processes and regulatory requirements to SD Biosensor throughout all stages of the product lifecycle, including research, design, development, transfer, validation/verification, labeling, regulatory submissions, and lifecycle maintenance.Works cross-functionally to ensure that quality and regulatory guidance is provided in support of business objectives.

Key Duties

Tasks/Duties/Responsibilities:

• Attend all Meridian-SD Biosensor project meetings to ensure that compliance with the regulations for the design, development and manufacture of medical devices are met and maintained throughout the lifecycle, especially US FDA’s QSR (21 CFR Part 820), ISO 13485, MDSAP and others as may be necessary.
• Participates in the development and execution of global regulatory strategy in collaboration with interdisciplinary project teams to support compliance with US-FDA regulatory and quality system requirements and overall business objectives.
• Support all activities related to management of Meridian's Quality System pertaining to bringing SDB product to the US market.
• Provide guidance and participate in drafting of regulatory submissions for domestic, world-wide commercialization and other business objectives, with a focus on US FDA Q-Submissions and Pre-market applications.
• Drafts, evaluates, and reviews technical protocols and data in support of clinical trials, validation, verification and product manufacturing.
• Maintain regulatory files, information, logs, and databases to ensure data continuity by collecting information and entering it accurately into various applications.
• Author and/or revise regulatory SOPs to align with current regulations and best regulatory practices.
• Coordinates the activities associated with adverse events, medical device reportable events and product recall activities, including corrections and removals.
• Completes the review and approval of product technical documentation (i.e. requirements documents, verifications/validations, Safety Data Sheets, manufacturing procedures, and labeling).
• Provides direct support associated with adverse events, medical device reportable events and product recall activities, including corrections and removals.
• Evaluates the regulatory impact of changes associated with product design change and routine change control.
• Drafts and reviews, and helps provide guidance for product labeling activities, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
• Provides regulatory input and oversight to product lifecycle planning, including risk management activities, and monitors product lifecycle and compiles information associated with changes as directed.
• Participates in long-term projects supporting the business and quality objectives of the organization.
• Assists in the management of third party and internal Quality Audit programs; perform supplier audit and verification activities as directed

• Physical:

• Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
• Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
• Ability to sit for long periods, stoop, reach and bend throughout the course of the work shift.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.

• Other:

• Ability to concentrate, problem solve and review paperwork for extended periods of time.
• Ability to analyze and interpret data.
• Ability to work outside of normal business hours to accommodate conference calls or business meetings as needed.

Qualifications

Minimum Education or Equivalent Experience Required/Preferred:

• Bachelor of Science degree in Engineering, Biology, Biochemistry, Microbiology or related field required.
• At least 5-6 years’ experience in FDA/ISO regulated industry; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent.
• At least 5-6 years of experience in the medical devices industry; experience regarding medical device design, development, and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, as well as ISO 13485 requirements.
• At least 5-6 years’ experience supporting medical device Quality Systems; proven experience with application of quality and regulatory requirements in the design and development of medical devices.
• Proven knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices), including risk management principles (e.g. ISO 14971).

Competencies Required or preferred:

• Must read, write and speak both English and Korean fluently and possess exceptional communication (written and verbal) skills, interpersonal skills, problem solving and ability to interact effectively with all levels of the organization both internally and externally.
• Extensive working knowledge of cGMP/QSRs, FDA device regulations, ISO 13485
• Thoroughly understands and can apply regulations and standards to new situations
• Demonstrate flexibility and agility in responding to shifting priorities, adjusting plans and approaches quickly to align with evolving business needs and objectives.
• Leverage strong interpersonal and communication skills to effectively influence key stakeholders, drive alignment, and achieve objectives, even in situations without direct authority or formal reporting relationships
• Demonstrated strong leadership, project management and organizational skills.
• Highly motivated, detail oriented, and must have a constant awareness of customer requirements; must demonstrate an ability to make fact-driven decisions and maintain accurate and concise records.
• Must be able to explain, clarify, educate, and train personnel to defend regulatory and quality system requirements of 21 CFR 820 and ISO13485 for the design, development and manufacture of IVDs.
• Must be organized with strong attention to detail and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast-paced environment.
• Readily adapts to changing priorities, effectively manages own time, sets priorities to ensure tasks, multiple projects are prioritized and completed on time.
• Ability to speak in large groups and actively engage participants.
• Strong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook)

Required Travel %:

• Position is hybrid:
  • Must be willing to travel to Cincinnati, OH on a regular basis (e.g., one week per month).
  • Must be willing to travel to Korea several times per year for several weeks per trip.

*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*