As Regulatory and Compliance Specialist you will support new product development and production facilities. The role will support continued growth of the company’s regulatory service offerings and customer requirements.
Act as core team member of RA/QA for project development life cycle.
Maintain State and Federal License renewals and annual registrations.
Coordinate with Notified Bodies, Competent Authorities and other regulatory agencies on submissions, audits, approvals or other issues
Ensure information relevant is available to customer submissions via Drug Master Files (DMF) or Device Master Files (MAF)
Develops regulatory strategy for difficult issues which could significantly impact project timelines and costs
Development, implementation and maintenance of regulatory SOP’s and development/improvement of processes and procedures
Ensures compliance with applicable national and international regulations and standards during all phases of the product life cycle.
Responsible for creating Clinical Evaluation Reports as needed
Performs compliance auditing activities.
Some programs may have vision requirements
BS/BA in science, engineering, business, quality/regulatory degree; Masters or industry qualification in Regulatory Affairs desirable.
Minimum 5 years’ experience in regulatory affairs within the Medical Device/Pharma industry
Knowledge of applicable international regulations and standards (CFR, MDD/MDR, QSR, ISO 13485, CMDCAS, etc.) preferred
Good knowledge of product development and processes
Experience with regulatory audits and inspections
Technical report writing skills
Skills and Abilities:
Leadership skills including ability to maintain confidentiality
Decision making and prioritization skills
Strong written, verbal and interpersonal communication skills with the ability to influence outcomes
Strong organizational skills with high attention to detail
Excellent team player, with ability to get along with colleagues and work as part of a team
Problem solving skills
Flexible attitude to work - ability to adapt to changing demands and requirements
This position does not qualify for VISA sponsorship
For further details of job location, company, etc. send your resume for immediate consideration to firstname.lastname@example.org