Senior Regulatory Affairs Lead

Dahl Consulting has a Senior Regulatory Affairs Lead that will provide regulatory support in any number of areas: review/analyze impact of modifications to manufacturing process, product, and packaging to the registration status of approved products and help determine the appropriate regulatory pathway, review/approve advertising & promotional materials, re-registration activities in support of US registrations, help develop regulatory strategies for new product development initiatives, and/or regulatory operations activities in archiving/assembling/publishing regulatory filings and other health authority communications.

Experience with MDD and MDR

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

Coordinate and submit licenses and authorizations for the maintenance of existing products, international registrations and dossiers, updates to DOC (technical files), engineering and device change requests.
Research, collect data, and respond to requests from regulatory agencies to prepare and submit documentation for marketing approvals (US, Canada and EU), as well as to provide routine regulatory information to associates and affiliates.
Provide regulatory guidance to product development teams and responds to product information requests.
Represent regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.
Prepare regulatory labeling requirements specifications for new and modified products; review product labeling for existing products to ensure compliance.
Assist in the development of best practices for Regulatory Affairs processes.
Provide Regulatory Affairs support during internal and external audits.
Adhere to environmental policy and procedures and support department environmental objectives.
Perform other duties as assigned by manager or supervisor.
EDUCATION & EXPERIENCE REQUIREMENT
Bachelors degree or equivalent education and a minimum of 7 years experience in the regulatory affairs area
Experience with technical files, regulatory registrations, recalls, MDRs, Vigilance reports
Good understanding and working knowledge of EU MDR, FDA and Canada medical device regulations, ISO 13485, Health Canada medical device regulations, ISO 14971 and MDSAP
Good verbal and written communication skills in English. Ability to read, write and speak English in order to comprehend and execute internal procedures and work instructions and communication to regulatory agencies
Must be detail oriented, have good organization skills, be self-motivated, work independently and take full ownership of his/her responsibilities
Knowledge of Sterilization methods
Good working knowledge of the manufacturing and quality operations.
Proficient in Microsoft Office

WORKING CONDITIONS & PHYSICAL DEMANDS

Regularly sit at a computer workstation
Must be able to fulfill all requirements for cleanroom access
Indoors, desk work, manufacturing floor and controlled cleanroom environment
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions