Job Description
Looking for an amazing Regulatory Affairs Specialist to join a growing startup medical device company! This Jobot Job is hosted by: Aaron Erickson
Are you a fit? Easy Apply now by clicking the "Apply" button
and sending us your resume.
Salary: $80,000 - $95,000 per year
A bit about us: Medical Device Manufacturer in Irvine CA is looking for a Regulatory Affairs Specialist to join their growing team!
Why join us? Great pay, benefits and work life balance
Job Details Job Details:
We are seeking a dynamic, experienced, and highly motivated Regulatory Affairs Specialist to join our team in the Medical Device industry. This position will play a crucial role in ensuring our company's compliance with all applicable domestic and international regulations, guidelines, and standards. If you have a passion for regulatory affairs, a keen eye for detail, and a background in working with Class III Medical Devices, this could be the perfect opportunity for you.
Responsibilities:
As a Regulatory Affairs Specialist, you will be responsible for:
1. Preparing and submitting regulatory documents such as 510k submissions, PMAs, and other pre and post-market regulatory applications to the FDA and other regulatory bodies.
2. Ensuring the company's products and procedures adhere to all domestic and international regulations, guidelines, and standards.
3. Participating in the development and implementation of regulatory strategies for new and modified products.
4. Reviewing and approving all product labeling, promotional materials, and changes to existing products to ensure regulatory compliance.
5. Interfacing with regulatory agencies and representing the company at meetings and inspections.
6. Providing regulatory input and guidance to cross-functional teams and ensuring the integration of regulatory requirements into project objectives.
7. Monitoring changes in regulatory landscape and updating internal teams on the impact of these changes on the company's products and processes.
Qualifications:
The ideal candidate for the Regulatory Affairs Specialist position should possess the following:
1. A Bachelor's degree in Engineering, Life Sciences, or a related field.
2. A minimum of 2 years of experience in Regulatory Affairs, specifically in the Engineering or Medical Device industry.
3. Proven experience with 510k submissions, PMAs, and other pre and post-market regulatory applications.
4. Solid understanding and experience with Class III Medical Devices.
5. Strong knowledge of domestic and international regulations, guidelines, and standards related to the Engineering or Medical Device industry.
6. Excellent communication and interpersonal skills, with the ability to effectively interface with various departments and regulatory agencies.
7. Strong analytical and problem-solving skills, with the ability to interpret regulatory guidelines and apply them in a practical and compliant manner.
8. Proficiency in Microsoft Office Suite, with strong skills in creating and managing regulatory documentation and reports.
9. Ability to work independently, manage multiple projects simultaneously, and meet deadlines.
If you are a dedicated and strategic thinker with a strong regulatory background and a passion for the Engineering industry, we would love to hear from you. Apply today to join our team as a Regulatory Affairs Specialist!
Interested in hearing more? Easy Apply now by clicking the "Apply" button.
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