Senior Regulatory Affairs Consultant

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Job description

About Sterling Medical Devices:

Sterling Medical Devices, a provider of custom electro-mechanical and software solutions for the medical device industry, has been dedicated to helping our clients resolve medical device development challenges. Our engineering teams address the whole development process: systems, software, electronics, mechanical, quality, and compliance. Our headquarters, located in Moonachie, NJ, is a casual work environment that engages our team in cutting edge technologies and projects.

Sterling has over 20 years of experience working with doctors, startups, medical device companies and providing solutions for healthcare companies that need to scale up quickly to bring medical device software, hardware, mechanical, and mobile medical device apps to market by successfully navigating the FDA and CE approval process. We design our client's products with a focus on the user needs and requirements, while making smart design choices based on our extensive and diverse product development experience.

The Opportunity:

We are currently searching for a Senior Regulatory Affairs Consultant to join our team. This position will be responsible for partnering with SMD team members to provide clients with regulatory direction for product development and guidance to develop rapid successful strategies for market approvals and regulatory compliance.

The role:

• Preparation of US and International submissions, preparing and reviewing documentation to ensure compliance with internal and external quality and regulatory requirements
• Help with development of regulatory strategies for product submissions
• Write, review, and assess test protocols and reports
• Coordinate, write and review regulatory assessments
• Assist clients in identifying required pre-clinical testing
• Perform literature reviews
• Identify and interpret Standards and Guidance Documents applicable to medical devices
• Ensure relevant ISO and FDA Export requirements are met, as required
• Participate in assigned project development activities to ensure compliance with regulatory requirements
• Review and advise project team representatives on labels, labeling, protocols, reports and proposed product changes
• Work collaboratively with cross functional groups to develop project/regulatory solutions.

Your Education and Experience:

• Bachelor's Degree in Science, Engineering, Healthcare, or related field
• Minimum of 5 years of medical device regulatory experience with current knowledge of medical device and/or biologics regulations.

• Familiarity with ISO 13485, US FDA QSRs, CE Marking, MDR,

• Experience in participating in regulatory audits/internal audits and inspections as appropriate
• Ability to professionally interact directly with government entities (e.g. FDA, notified bodies, etc.) on regulatory filings
• Ability to assess regulatory impact of design and/or manufacturing changes
• Knowledge of quality control processes and statistical techniques
• Demonstrated understanding of various types of mechanisms, materials, proper tolerance, drafting standards, and GD&T.
• Demonstrated competence in technical writing: protocols, testing results, procedures, statue and special reports
• Human factor requirements: Conduct of Human Factors Evaluations (HFE) for new or revisions to devices per US FDA Applying Human Factors and Usability Engineering to Medical Devices (2016), AAMI/ANSI HE75, IEC 62366
• Strong analytical and problem-solving skills; strong attention to detail
• Ability to read, analyze and interpret complex data and review technical documents
• Excellent verbal and written communication skills
• Strong interpersonal skills and the ability to work with cross-functional teams
• Project management experience preferred.

Sterling Medical Devices (SMD) is an Equal Opportunity Employer. SMD does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need."

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