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)

Knowledge, Experience and Technical Skills

• 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

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.

Physical Demands

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Requires prolonged sitting and working at a computer monitor. Repetitive motion using a keyboard for long periods of time. May occasionally be required to lift and move material weighing up to 10 lbs.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Agreeable work environment typical of an open office setting with some exposure to noise from office machines.
• This position will require a minimum of 3 days on site in the Milford office.

INDUS