The Regulatory Affairs Specialist (RAS) works to gain successful 510k approval by leveraging their skills and expertise to anticipate regulatory requirements and integrate compliance into project plans. The RAS streamlines preparation and submissions, by ensuring documentation is accurate, complete, organized and accessible. The RAS will work effectively with other departments to compile information and ensure that compliance requirements are met throughout the product lifecycle. Primary function: successfully gain 510k & NDA approval with USFDA Other responsibilities: - Represents regulatory affairs and serves as a liaison between regulatory bodies when working with cross-functional teams by providing regulatory feedback and guidance throughout the product development cycle.
- Research, develop and implement regulatory and compliance strategies for new and modified medical devices in accordance with applicable regulatory bodies.
- Prepares and submits applications and reports to applicable regulatory agencies of medical devices.
- Responds to all requests for information from regulatory bodies in a timely and organized manner.
- Maintains a current and working knowledge of regulations applicable to the company.
- Develop and maintain positive and professional relationships with device reviewers through oral and written communications.
- Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
- Compiles and communicates regulatory impact assessments and submission approval status reports.
- Supports various audits.
- Other Responsibilities
- As assigned
To be considered you’ll need:
- A minimum of 3-5 years of relevant work experience in regulatory affairs, specifically working to compile and submit 510k applications
- Bachelors degree in a relevant field preferred
- Strong knowledge of medical device regulations and standards
- Experience with regulatory submissions and interactions with regulatory authorities
- Solid company-centric ideology.
- Creative problem-solving skills.
- The ability to balance multiple priorities.
- Core values of honesty and respect.
- The desire to be challenged.
You will thrive if you: - Enjoy an autonomous work environment.
- Have a LEAN mindset.
- Are the first person to help.
- Seek out opportunities to bring added value.
Company Benefits & Perks
- 401K
- Health Benefits: Medical, Dental, Vision
- Wellness Program
- Life Insurance
- Corporate Sponsored Events
- Skill growth opportunities
- Short Term Disability
- Ability to Advance
- Working with energetic & creative problem solvers
- A mission worthy of your energy and expertise
Applicants for this position must successfully pass background, drug screen and reference check. It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.
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