Offered Management Position - Limited Experience - Any Concerns?

[MDDRegAffairs]

Hello All,

I have recently started an internship with a small company (<30) to perform regulatory compliance. The position opened after the prevoius director of QA/RA left for another job. Since then a new director of QA has been appointed and RA was divided among the lower level QA employees. The company is proposing I take the job title "director of regulatory compliance" at the end of my intern. Are there any troubles (i.e., legal) I could get myself into by taking this position?

Any comments would be greatly appreciated,

Regards

MDD

 

[John Broomfield]

Re: Offered Management Position; Limited Experience; Any Concerns?

Hello All,

I have recently started an internship with a small company (<30) to perform regulatory compliance. The position opened after the prevoius director of QA/RA left for another job. Since then a new director of QA has been appointed and RA was divided among the lower level QA employees. The company is proposing I take the job title "director of regulatory compliance" at the end of my intern. Are there any troubles (i.e., legal) I could get myself into by taking this position?

Any comments would be greatly appreciated,

Regards

MDD

MDD,

If you enjoy the work you may be good at it. Define any missing skills or knowledge you need to be competent.

Gain the agreement if your boss to fund the learning you still need.

And enjoy developing your experience at deploying regulatory requirements to your organization's management system, providing training as necessary for assuring compliance and for evaluating compliance.

You could also seek a mentor here or from your professional institution.

If you do not enjoy the work, politely decline the offer in favor of what you would enjoy.

John

 

[Sarah Stec]

Re: Offered Management Position; Limited Experience; Any Concerns?

Titles and responsibilities can be two different things in different jurisdictions. Off the top of my head, in the US, unless you deviate from your responsibilities, and/or the company commits a crime that you should have stopped/known about and reported, you may not have additional legal responsibilities.

You may be required to be the regulatory contact for your company's regulators, but that would be detailed in your responsibilities. Likewise, you may be required to sign off on regulatory submissions (again, this should be included in your responsibilities and signature delegation). But, as with everything else, don't sign off on something that you can't stand behind while being grilled by opposing counsel.

You should consult your company's executives/outside counsel to see if your title of Director = "on the Board of Directors," which would impart more responsibility than a manager-type role.

Don't be afraid to ask questions about your responsibilities. If you aren't sure if something is your duty, and it turns out it is, then you could be on the hook. And don't be afraid to ask if you're main responsibilities are for product compliance or company compliance, or both. Regulations that govern products are different from those that govern companies and both change fairly often, so it should be clear what is the scope of your responsibilities. Keep in mind that as your company grows, this may change as well.

If you carry a specific license, like you're an attorney and you have the title of Director of Regulatory Compliance, then you have to take into account the other ethical and practical guidelines of your licensed profession as well as your job responsibilities.

You mention that you're an intern. Do you have previous experience with regulatory compliance?

 

[MDDRegAffairs]

Re: Offered Management Position; Limited Experience; Any Concerns?

Sarah,

Thank you for the comments. A mentor is one thing the position lacks significantly. Do you have any recommendations on how to find an appropriate mentor?

Regards,

MDD

 

[John Broomfield]

Re: Offered Management Position; Limited Experience; Any Concerns?

Sarah,

Thank you for the comments. A mentor is one thing the position lacks significantly. Do you have any recommendations on how to find an appropriate mentor?

Regards,

MDD

MDD,

Join your professional association and attend meetings and conferences. You'll find all sorts of professionals willing to mentor newbies.

Indeed, it is usually one of the obligations of joining that profession.

John

 

[Sarah Stec]

Re: Offered Management Position; Limited Experience; Any Concerns?

True mentors are hard to come by and require some time commitments from both parties, and you may want more than one for different situations or responsibilities. But I think they can be found in places you already know. For example, my Dad ran very successful stores and worked for giant corporations in high positions all his life, so I go to him to bounce off management ideas/issues. But he isn't quite sure what it is that my company does. So, I go to someone else when I have a question as to the regulations and standards we follow and how we should follow them. And I got to yet someone else if I need someone to tell me if I'm crazy when I say, "This is OK, right?"

Where to find them - anywhere and everywhere. Some are colleagues, others are people I've met at conferences, others are friends I've had for a long time, others are family. You could do some informational interviews and get some advice as to what you should watch out for in your new position. In my experience, if they're willing to sit down with you and give you advice, they'll want feedback as to how their advice went. This is the foundation of a mentoring relationship, as if it went well, they'll be happy to impart their wisdom again.

 

[Ronen E]

Re: Offered Management Position; Limited Experience; Any Concerns?

Hi MDD,

I would not title myself "A mentor" but I would definitely be glad to discuss all sorts of issues related to medical devices regulatory affairs - either here (in the public area) or in private messages / email if confidential issues are at stake. Sitting down with you might be difficult unless you're in Australia, but a phone call is always possible.

Good luck either way,
Ronen.

 

[MDDRegAffairs]

Re: Offered Management Position; Limited Experience; Any Concerns?

Sarah,

I have a master's degree in biomedical product development which covered some regulatory component. I am not part of the board but will act as a liason for regulators.

 

[MDDRegAffairs]

Re: Offered Management Position; Limited Experience; Any Concerns?

John,

My apologies, got confused with the nest as presented on my phone. Thank you for the comment of seeking professional associations. I am an active member of AAMI. Can you recommend any other associations to join or conference to look for?

 

[MDDRegAffairs]

Re: Offered Management Position; Limited Experience; Any Concerns?

Ronen,

Thank you for extending that offer, it is greatly appreciated. I am quite a distance from Australia at the moment, though the pacific does sound nice.