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Career Story: Director Of Regulatory Affairs For A Medical Device Contractor

Director Of Regulatory Affairs For A Medical Device Contractor

Job Title: Director

Type of Company: Contract research testing of medical devices and pharmaceuticals.

Education: BA, Biology, St. John Fisher College

Previous Experience: I worked as a laboratory technician for three years, then became a lab manager and a lab operations manager. I moved into a regulatory role and have since been promoted to director.

Job Tasks: As the director of regulatory affairs and quality assurance, my primary responsibilities are to assure that the company follows all federal, state and local laws that apply to operating a laboratory. The laws apply to documentation practices, scientific integrity, and scientific accuracy. In addition, there are laws that govern the health and safety of the employees, hazardous materials and hazardous waste handling, facility maintenance, and training. We have to adhere to those too.

The testing programs that the regulatory and quality groups monitor are to support the safety of medical devices and pharmaceuticals for both FDA approval (in the US) and country by country international approvals.

My group also manages all company inspections of our facility and records. These inspections may be performed by a government agency or by our own customers.

Best and Worst Parts of the Job: The best part of the job is the variety of programs we offer and the interactions with people of varying backgrounds. Some are Ph.D. scientists and others are college level technicians.

The worst part of the job is dealing with individuals who do not understand or follow the rules and regulations that have been put in place to assure the integrity of the work conducted.

Job Tips:
1. Whatever type of work you plan on pursuing, take business courses. If you are hoping to become a chemist or a biologist, someday you may grow into a management role and many employees in these fields have no business management knowledge. 2. Don't look to start at the top, be patient with entry level positions. Learn and master each level.

3. A person who does a great job, no matter how tedious the task, is the first person promoted. Don't look to move out of a role that you are not performing at the top.

4. Your success at your very first job is where your next job comes from. You need excellent references to move forward.

Additional Thoughts: If you are considering a scientific career, try a variety of types. Be careful not to take a position in a large company where it can be hard to get recognized and your exposure to things is restricted. Look for small- to mid-sized companies for the greatest exposure.

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