Job Description
Description The Regulatory Affairs Specialist works under minimal supervision supporting cross- functional teams with regulatory strategy and execution for new devices and device modifications.
Responsibilities - Participate as the regulatory representative supporting cross-functional project teams.
- Draft and execute regulatory strategies for new product development and device
modifications, including identifying regulatory risks, tracking timelines and submission
deliverables, and establishing contingency plans. - Support RA functional area in the review and approval of change orders, including writing
letters to file where applicable. - Obtain market clearance and approvals for class II and III medical devices, including (but
not limited) to 510(k)s, IDEs, pre-submissions and PMAs. - Create and review project deliverables for regulatory submissions.
- Interact with regulatory agency authorities for initial submission and query resolution.
- Review and approve device labeling and promotional materials.
- Maintain and sustain existing product lines.
- Support quality system changes, improvements and audits as needed.
- Develop and maintain regulatory procedures.
- Assist in keeping the company informed of current and proposed regulatory requirements.
- Provide cross-functional support for the OUS Regulatory team as needed.
- Perform additional duties as assigned.
Qualifications - Bachelor's degree in life sciences, engineering, or related field preferred.
- Minimum 2 years of experience in medical devices regulatory affairs or relevant function with Bachelor's degree OR minimum 1 year of experience with an advanced degree.
- Detail oriented with well-developed writing and analytical skills.
- Excellent, proven interpersonal, verbal, and written communication skills.
- Experience in Microsoft Office Suite, including Word, PowerPoint, Excel.
- Interpret subjective and complex aspects of specific regulations, with thorough understanding of multiple sets and tiers of associated regulations.
Preferred - Regulatory Affairs Certification preferred.
Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $75,000 - $90,000. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary.
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.
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