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Regulatory Affairs Specialist II - BIOFIRE Molecular (Premarket Team)

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Location: Salt Lake City, UT, United States
Position Type: All
Job Function: Regulatory Affairs

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A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

Responsibilities:

  • Perform all work in compliance with company policy and within the guidelines of its Quality System.
  • Develop global regulatory strategy for new products.
  • Prepare and submit U.S regulatory submissions [Pre-Submissions, 510(k)s, direct de novo applications, etc.]
  • Prepare and maintain product Technical files for CE marking.
  • Analyze and understand regulatory requirements and identify solutions; provide directions for proper implementation.
  • Organize and prepare documents for international submissions. Coordinate with international counterparts to obtain product approvals and renewals.
  • Conduct research on regulatory changes and developments on application requirements.
  • Collaborate with and provide regulatory insight to new product development teams. Advise project teams on subjects such as premarket requirements, timelines, compliance issues and export and labeling requirements.
  • Support review of labeling and marketing materials.
  • Maintain current knowledge of existing and emerging regulations, standards, and guidelines. Assist in keeping the company informed of these requirements.
  • Prepare product field action and MDR reports.
  • Interpret regulatory rules, assess rule changes, and ensure their proper communication through corporate policies and procedures.
  • Review and assess product change impacts (device/labeling) for US and international markets and craft regulatory notification plans.
  • Assist in the development and review of corporate and department procedures.
  • Prepare and direct timely preparation of additional information and responses requested by regulatory agencies.
  • May mentor and lead others in department.
  • May participate in audits.
  • Can lead projects on their own.

 

Training and Education:

  • Bachelor’s degree or equivalent. Science background is preferred.

 

Experience:

  • 4+ years in regulatory affairs, medical device/IVD experience preferred.

 

Skills and Qualifications:

  • Ability to work effectively with multiple disciplines and personalities.
  • Self-starter, with the ability to work and learn independently.
  • Demonstrate initiative and can work both independently and collaboratively in a team structure.
  • Understanding and familiarity with FDA and European regulatory requirements, guidelines and expectations.
  • Strong attention to quality/detail.
  • Strong interpersonal and communication skills (written and verbal).
  • Ability to handle multiple tasks and priorities.
  • Proficient with computer and standard software programs (Microsoft Office, Adobe Pro).
  • Excellent organizational, time management, and administrative skills.

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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