Agreed! Evaluators are people as well, we can make their job easier which means faster turnaround time for us
A good Regulatory Affairs Manager
- Thread starter Auxilium
- Start date
Agreed! Evaluators are people as well, we can make their job easier which means faster turnaround time for us
Well, actually I did never feel completely ready for audits, but being the only regulatory person in my small company, I had to manage them anyway. I was supported by a consultant in our first CE and ISO audits and in the first FDA audit, from the next ones I've managed them by myself.
So, if you have the possibilities to attend to audits as an observer, do it since now! Otherwise, maybe asking for an external support may be helpful.
CreatureofCompliance
Registered
-Stay up to date with all the regulatory requirements with webinars, discussions, conferences, websites
-Upskill through continuous education. Plenty of SaMD courses available for in-depth knowledge of this area
-Put yourself forward to train in new areas that you are weaker in
-Put yourself forward to assist more experienced colleagues in any projects that they may require help with (no matter how basic)
-What I have learned is that Regulatory Affairs is a constantly evolving area and you have to have a mindset of staying curious and collaborating with others
-Stay humble- don't assume you know everything- because that is impossible
-Upskill through continuous education. Plenty of SaMD courses available for in-depth knowledge of this area
-Put yourself forward to train in new areas that you are weaker in
-Put yourself forward to assist more experienced colleagues in any projects that they may require help with (no matter how basic)
-What I have learned is that Regulatory Affairs is a constantly evolving area and you have to have a mindset of staying curious and collaborating with others
-Stay humble- don't assume you know everything- because that is impossible
mihzago
Trusted Information Resource
What do you mean when you say 'Manager', because to me it means someone that typically manages others. So do you want to be someone that understands the topic and want to manage others or do you rather mean you want to become a better subject matter expert?
Either way, the number one for me is to understand the intent of the regulation as it applies to your organization and not just apply a requirement because was done that way somewhere else.
Either way, the number one for me is to understand the intent of the regulation as it applies to your organization and not just apply a requirement because was done that way somewhere else.
WAQAR-QMS
Medical Devices Expert
I would like to propose a direction for you !!!
Be a Problem Solver, the routine is cake.
Choose your preferred Medical Device Type at first, in which you are good and it appeals.
Identify markets for the medical device and relevant rules (as in Europe every country have its own set of rules), so does outside Europe.
Work it out in every possible way; the more diverse environment or scenarios you will work, the most possible outcomes you will enjoy.
Explore more than usual people do, Read, analyse and adopt more than usual is what it requires.
Happy Hunting
Be a Problem Solver, the routine is cake.
Choose your preferred Medical Device Type at first, in which you are good and it appeals.
Identify markets for the medical device and relevant rules (as in Europe every country have its own set of rules), so does outside Europe.
Work it out in every possible way; the more diverse environment or scenarios you will work, the most possible outcomes you will enjoy.
Explore more than usual people do, Read, analyse and adopt more than usual is what it requires.
Happy Hunting
ChrisM
Quite Involved in Discussions
You need to be a good communicator and influencer too.
It's not good enough to just stand up and say "we have to do this because compliance is not an option"; you need to be constantly aware of what is going on in the Regulatory World and be able to raise points at, for example, Management Reviews pointing out how proposed future changes to regulations may affect the way t]your company does business, manufactures its products, what records it keeps etc.
I've had the experience of working in Medical Device Companies that have Quality and Regulatory Departments; in one case the Quality and Regulatory staff were generally kept at arms' length from each other; I can assure you that this was more burdensome and caused more issues than where Quality and Regulatory staff were constantly interacting with each other; enabling each to see the other's points of view etc was of great benefit
It's not good enough to just stand up and say "we have to do this because compliance is not an option"; you need to be constantly aware of what is going on in the Regulatory World and be able to raise points at, for example, Management Reviews pointing out how proposed future changes to regulations may affect the way t]your company does business, manufactures its products, what records it keeps etc.
I've had the experience of working in Medical Device Companies that have Quality and Regulatory Departments; in one case the Quality and Regulatory staff were generally kept at arms' length from each other; I can assure you that this was more burdensome and caused more issues than where Quality and Regulatory staff were constantly interacting with each other; enabling each to see the other's points of view etc was of great benefit
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