Regulatory Affairs Manager

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Job description

Kelly ® Science & Clinical is seeking Regulatory Affairs Manager professionals who are eager to bring the latest scientific discoveries to life in order to create a brighter, safer and healthier future for all. If you're passionate about shaping the world we live in and ready for a new challenge, this may be the perfect opportunity for you.

Manages the day-to-day activities of the Regulatory Affairs department.

Responsibilities:

• Hires, evaluates and assigns work tasks to departmental employees.
• May manage audits from outside regulatory agencies.
• Ensures that Merit is aware of domestic and international laws and regulations that govern regulated medical products.
• Informs staff personnel and other Merit employees of regulations and laws that pertain to their respective responsibilities and that relate to the legal manufacture and sale of medical devices, including anticipated changes in regulations or in the interpretation of the law by regulatory agencies.
• Works with other staff in resolving regulatory and technical problems.
• Performs a variety of other functions related to representing Merit in dealings with regulatory agencies.

Minimum Qualifications:

• Bachelor's degree in Engineering or Science or related scientific discipline, or equivalent. Higher degree/PhD will be preferred for senior level positions.
• Relevant regulated industry experience (i.e., FDA or EMA).
• Experience working at the FDA is highly preferred.
• Experience filing IND/NDA submissions (check which Phase of Clinical Development the talent has, or the client requires).
• Experience with interacting with specific Divisions within the FDA (i.e., CDER or CBER).
• Knowledgeable of FDA Clinical Trial Guidance's and regulations, pharmaceutical development process, and industry standard practices.
• Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms, annual reports, IND applications, IDE applications, and summary report.
• Regulatory correspondence with PI's and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates.
• Maintain TMF related to ongoing studies and all regulatory documentation.
• Working knowledge of database management programs, analytical tools, and CTMS.

#TJP2021_SPEC

#TJP2021_SCT

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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