Regulatory Associate

SUMMARY:

The Regulatory Associate 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, draft 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 new product development, serving as Regulatory representative, ensuring project deliverables have been prepared in accordance with medical device regulations and standards
• Support activities required for regulatory strategy development, including research of standards and guidance documents, and communication of the information pertaining to the appropriate regulatory pathway for new or modified products
• Draft US FDA 510(k) submissions, Letters to File, and associated forms and documents
• Support domestic and international registration of medical devices
• Assist in preparation of MDR technical documentation for a range of device classes
• Support post market activities, including performing post-market surveillance activities, supporting submission of vigilance reports, and supporting recall and correction activities
• Enter products into the GUDID database upon placement in market
• Support all QMS/product audits from FDA or other authorized regulatory authorities
• Draft content for the development of IFU package inserts
• Review all labeling, including surgical techniques and product labels
• Review and evaluate promotional and advertising material for compliance with applicable regulations
• Miscellaneous responsibilities, as assigned

QUALIFICATION / EXPERIENCE REQUIREMENTS:

• Bachelor's degree or equivalent required, scientific field preferred but not required, depending on other qualifications
• 1+ years' experience in Quality / Regulatory Affairs, including preparation of submissions to FDA, EU, or other regulatory bodies
• 1+ years' experience in medical device
• Combination of education, experience, leadership, strategy, and QA/RA influence may be considered

OTHER SKILLS AND ABILITIES:

• Proficient in Microsoft Office suite
• Ability to work well both independently with supervision and in a group
• Strong interpersonal, organizational, problem-solving, analytical skills, and strong attention to detail
• Demonstrated strong writing and communication skills
• Ability to manage competing priorities; versatility and willingness to work with changing priorities
• Must work precisely according to procedures, rules, and regulations and has a passion for continuous improvement and quality
• Able to demonstrate the highest ethical standards, actively promotes trust, respect, and integrity in all dealings, both inside and outside of the Company
• Must have service-oriented approach and be flexible and proactive towards changing needs, willing to pitch in and help wherever needed

Current Openings for Regulatory Associate Jobs at XXX DO NOT USE XXX WishBone Medical, Inc

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Our team comes from a variety of backgrounds, but there's one thing you'll see across the board:
Passion and purpose in all that we do.

Simply put, we love our jobs.

But how can we not?! When going to work each day means helping kids around the world...

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