Regulatory Affairs Manager

Job description

Do you enjoy designing and enforcing company procedures that are comprehensive, practical, and efficient?

Medicreations is an aesthetic device manufacturer building equipment right here in Las Vegas. We design advanced medical-grade machines that help doctors, estheticians, and salon owners deliver stunning transformations to people who want to look and feel better. These devices, in some cases, are high-intensity energy machines that strictly follow FDA guidelines.

While we already have much of the framework in place, we are looking for someone to help build out the full regulatory framework for the business, starting from the design process of the devices themselves to marketing compliance.

You’ll need an incredible level of attention for detail. The ability to quickly comprehend extremely complicated regulatory jargon. And there will be paperwork. So much paperwork.

If that makes you sit up and say “Yes, that’s me!” then we’d love to hear from you.

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Duties And Responsibilities:

Assume responsibility for Design Assurance of Medicreations LLC Products:

• Adhere to Medicreations employee policies

• Additional duties and some travel may be assigned.

• Develop and maintain standard operating procedures or local working practices to ensure regulatory compliance.

• Assure compliance with Design Control policies and procedures

• Work hand-in-hand with engineering to ensure design history files and technical files a kept current

• Review and approve changes to Design, Software, QMS, or Product Range by assessing the impact on design and processes from a regulatory standpoint.

• Provide regulatory input to product lifecycle planning

• Assure compliance with Risk Management policies and procedures

• Participate in risk-benefit analysis for regulatory compliance

• Work with engineering to document the analysis of new or modified risks due to design, software, or process changes

• Reviews labeling (Instruction for Use, labels, promotional materials) for compliance to standards, guidelines, and regulatory approvals/clearances.

Assume responsibility for preparing US regulatory submissions:

• Filing necessary applications and handling all government interactions.

• Responsible for assisting in the preparation and compilation of domestic and international product registration submissions, with guidance. This includes, but is not limited to, 510(k) submissions, international dossiers, and CE technical files.

• Monitor Submissions under review and coordinate timely response to any questions/requests for information from FDA.

Assume responsibility for compliance with Regulatory Reporting requirements:

• Provide support to audits and inspections by regulatory agencies as needed.

• Support medical device reporting, vigilance, and recall-related activities.

• Monitor and work with complaint department to submit applicable reports to regulatory authorities

• Ensure product safety issues and product associated events are reported to regulatory agencies

• Ensure compliance with product post-marketing approval requirements.

• Monitor and understand changes to the regulatory environment, including relevant domestic and international standards, regulations, and guidance documents. Implement such changes as required.

• Oversees the regulation process for products requiring governmental approval

• Train staff in regulatory policies or procedures.

• Coordinate internal discoveries and depositions with legal department staff.

• Coordinate inspection of the organization and contract facilities

Qualifications:

• Bachelor's degree

• 2 years of regulatory affairs experience in the medical device industry.

• Proficient understanding of US FDA and EU Medical Device regulatory requirements.

• Knowledge of quality system requirements such as ISO 13485 and FDA 21 CFR Part 820.

• Knowledge of product development processes in the medical device industry.

• Must be computer-savvy and well-versed in document editing software i.e. Adobe Reader, etc.

• Effective technical writing and verbal communication skills.

• Strong communication, presentation, and interpersonal skills.

• Great attention to detail with excellent organizational and coordination abilities.

• Self-directed, the ability to work independently, and is highly motivated.

• Ability to function in a fast-paced and deadline-driven environment.

• Fluent in English (fluency in other languages is a plus).

Working Conditions:

The Regulatory Affairs Manager would work in an office environment that includes laboratory and manufacturing areas. Occasional travel may be required.

The Regulatory Affairs Manager would work a standard workweek but may be required to work some evenings to meet the needs of the company.

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What You Can Expect From Medicreations:

• Salary: Up to $70K/year based on experience

• Benefits: Paid time off company health plan

• Comprehensive COVID-19 safety protocols

• Free or heavily discounted aesthetic treatments

• A gorgeous office and great coffee

• An amazing team to back you up

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, gender identity, disability, protected veteran status, or any other characteristic protected by law. We will consider employment qualified applicants with criminal histories consistent with applicable law.

Job Type: Full-time

Pay: Up to $70,000.00 per year

COVID-19 considerations:

We have sanitation stations around the building, and masks are required under specific conditions.