LGC is a leading, global life science tools company, providing mission-critical components and solutions for high-growth application areas across human healthcare and applied market segments. Our high-quality product portfolio comprises mission-critical tools for genomic analysis and quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range.

Our tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimize food production; and continuously monitor and enhance the quality of food, the environment and consumer products.

LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community. Join us and help us achieve our mission of Science for a Safer World!

Job Purpose

The Regulatory Affairs Specialist position will be responsible for product submissions, license renewals, periodic updates, and registrations to regulatory agencies. Organize regulatory information and track and control submissions, review and advise on labelling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues.

Key Responsibilities

• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies and advise on the submission strategy for new products.
• Compile materials for license renewals, updates and registrations.
• Establish and maintain system for tracking changes in documents submitted to agencies or partners.
• Assist in preparing and maintenance of Technical Documentation for product registration and submissions to EU, US, and International Competent Authorities and / or Regulatory Agencies.
• Review labelling for compliance with regulatory requirements.
• Review changes to existing products and SOPs to define the requirements for regulatory submissions.
• Ensure compliance with all documented Quality system requirements, as per FDA QSR’s and ISO 13485.
• Provide the regulatory reviews of customer complaints and define the regulatory reportability.
• Provide input in to Post Market Surveillance and Risk Management processes.
• Responsible for timely FDA registration of facilities and FDA preparedness activities.
• Maintain current knowledge of FDA, DEA, and international regulation, guidance, and standards, including, but not limited to ISO, IVDR, and CA SOR, applicable to our products.
• Actively participate in evaluation of regulatory compliance of document / product/process /test methods changes.
• Maintain a current library of external standards to which the company complies, evaluate the impact of changes of external standards to quality systems through gap analysis, and implement required changes.
• Participate in research of regulatory issues and dissemination of regulatory information.
• Serve as the Person Responsible for Regulatory Compliance (PRRC)

Education and/or Experience

• A Bachelor’s Degree in a Scientific Discipline or related
• At least 3 years in a Life Science, cGMP/ISO environment in a regulatory affairs role, with direct experience in an IVD/Medical Device environment preferred.
• Working knowledge of FDA QSR/cGMP regulations as well as ISO 13485 required. Knowledge of US and international medical device regulatory requirements required.
• Experience with Class I and II devices and IVDR implementation is desired
• Embrace LGC culture and values, displaying the ability to easily adapt and absorb knowledge within a fast-paced environment to ensure that all commitments are met, while maintaining effective relationships with members of the LGC team, customers, and suppliers

What we offer (US-based-employees):

• Competitive compensation with a strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical illness insurance
• 401(k) retirement plan with a matching employer contribution
• Company-paid short- and long-term disability, life insurance, and employee assistance program
• Flexible work options
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Companywide social events, frequent catered lunches, and much more!

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay
• Commission pay
• Signing bonus

Application Question(s):

• Desired salary?

Work Location: One location

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