Senior Regulatory Affairs Specialist

Orthofix•Carlsbad, CA

1d•$97,000 - $128,500

About The Position

Why Orthofix? Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further. How you'll make a difference? Ensure domestic and international regulatory submission and reporting activities are completed in a timely manner so that full compliance with all applicable global regulatory requirements and internal product/project goals is maintained. What will be your Duties and Responsibilities? Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Requirements

College degree or equivalent work experience in Regulatory, Quality or R&D.
Minimum of 5 years experience in Regulatory Affairs.
Experience with FDA QSR requirements, ISO 13485, and EU Medical Device Directive regulatory requirements
Excellent oral and written communication skills.
Public speaking proficiency.
Willing to mentor others.
Ability to prioritize, conduct team meetings, and meet project deadlines.

Nice To Haves

Science or technical degree.
RAC Certification.
Experience with ISO 14971

Responsibilities

Prepare domestic and international product submission and reports including: U.S. FDA 510(k)s, IDEs, PMAs, annual reports, international product registrations, MDRs, Vigilance Reports and Problem Reports.
Prepare Technical Files.
Prepare and review product labeling.
Prepare correction and removal (recall) reports and coordinate recall related activities.
Provide regulatory affairs support to project teams.
Develop regulatory strategies for new products.
Review design changes and assess regulatory implication relative to the design change.
Provide regulatory support for quality system related changes i.e. ECOs, MCOs, NCMRs, SDRs, etc.
Help drive process and compliance improvements activities.
Lead health hazard evaluations to determine risk associated with post-market product issues.
Provide regulatory affairs support during external inspections ( FDA, BSI, etc.).
Provide regulatory affairs guidance to other Orthofix departments, as necessary.
Regular attendance required.