Senior Regulatory Affairs Specialist

SUMMARY:

The position of Sr Regulatory Affairs Specialist is responsible for regulatory affairs and regulatory compliance items for WishBone Medical, Inc. per the direction of the VP of QA/RA. The primary focus is to support product development teams during product development from a regulatory perspective, write regulatory submissions, review marketing collaterals for consistency to approved intended uses, and perform tasks to ensure post market compliance. Regulatory affairs support may be required for additional geographies.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)

· Core team member for product development, serving as Regulatory representative, ensuring project deliverables have been prepared accordance with medical device regulations and standards

· Lead activities required for regulatory strategy development, including research of standards and US FDA guidance documents, and communication of the information pertaining to the appropriate regulatory pathway for new or modified products

· Write US FDA regulatory submissions and associated forms and documents

· Supporting post market activities, including performing post-market surveillance activities, supporting submission of vigilance reports, and supporting recall and correction activities

· Supervise entering product status into the GUDID database upon placement in market and mentoring of other Regulatory Affairs associates

· Support all QMS/Product audits from the FDA or authorized regulatory authorities

· Write package inserts. Review all labeling, including surgical techniques and physical package labeling

· Review and evaluate promotion and advertising material for compliance with applicable regulations

· Miscellaneous responsibilities, as assigned

EXPECTED AREAS OF COMPETENCE:

· Strong interpersonal, organizational, problem-solving, and analytical skills with strong attention to detail

· Demonstrated strong writing and communication skills

· Ability to manage competing priorities and versatility and willingness to work with changing priorities

· Must work precisely according to procedures, rules, and regulations, and have a passion for continuous improvement and quality

· Able to demonstrate the highest ethical standards, actively promote trust, respect, and integrity in all dealings, both inside and outside the Company

· Must have service-oriented approach, flexible, and proactive towards changing needs

· High level of proficiency in Microsoft Word, Outlook, Excel, and PowerPoint is essential

QUALIFICATION / EXPERIENCE REQUIREMENTS:

· Bachelor's degree or equivalent is required, scientific field preferred

· 3-5 years of experience in Quality / Regulatory Affairs, including preparation of 510(k) submissions to the FDA

· 2+ years of experience in medical device

· A combination of education, experience, leadership, strategy, and QA/RA influence may be considered

Current Openings for Senior Regulatory Affairs Specialist Jobs at XXX DO NOT USE XXX WishBone Medical, Inc

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