Position title
Regulatory Affairs Specialist-Cleveland
Description

Are you a life science Regulatory Affairs professional who would like to advance your career into different product portfolios, while being mentored by the team's in-house Regulatory Expert?

Do want the flexibility to work from home, with only being in the office 1-2 days/week?

Do you want to work for a company with very little turnover, that values work/life balance?

If so, this position is for you!

The person hired for this role will be the point person for regulatory strategy and execution across the customer portfolio, with a focus on pre-market activities for product development, and will report to the Business Owner. As the company scales, this role could develop to be a leadership position as additional Regulatory Affairs support is needed to grow the business.

This is a high caliber team with an excellent reputation in the industry. There is very little turnover here as work-life balance is a real thing, where many people take Friday afternoons off and/or work remotely part of the week. They work in tandem towards achievable results with needed resources to succeed. They have work days dedicated to philanthropy, they celebrate wins and know they can forge their own path with their career here.

If you’d like to learn more, please apply here. We will be reaching out ASAP to all qualified applicants.

Responsibilities:
• Devise and execute with regulatory pathways and strategies, premarket FDA, and international regulatory submissions.
• Serve as point person for external audits by regulatory and third party auditors.
• Support post-market surveillance activities as needed.
• Perform gap assessments against new and revised regulations.

Qualifications:
• Bachelor’s Degree.
• 3-7 years of Regulatory Affairs experience in the medical device or other area of life science industry.
• FDA regulatory submission experience (Pre-Submission, 510Ks, De Novo, IDEs) and international submission experience a plus.
• Extensive project management skills with the ability to work under deadlines, handle multiple priorities simultaneously, and work across multi-disciplinary teams.

Beginning of employment
ASAP
Industry
Life Sciences
Job Location
Pittsburgh, PA, USA
Remote work possible
Date posted
March 9, 2022
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Position: Regulatory Affairs Specialist-Cleveland

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