Resume Feedback - Medical Device (SaMD) Regulatory Affairs, 5 YOE

Hey all,

Hoping to receive some feedback on my resume. I am having a hard time receiving a phone screen for any senior+ medical device regulatory affairs/quality roles even though my experiences are extremely solid IMO. My most recent role was working for a tech giant leading Post Market Surveillance.

Based on my experiences and career development, I would say that I am ready for a management role or staff level IC role; however, I would love to hear your thoughts. Even applying broadly from Specialist roles to Principal level roles where I meet the bar in terms of qualifications, I have received 0 phone screens. It's a bit demoralizing especially since I view my experiences as unique and fairly rare.

Pasting the resume raw below since I cannot attach links or photos yet.

Big Tech Company

Senior Regulatory Affairs Program Manager Late 2022 – Present

• Managed end-to-end resolution for 1100+ customer complaints for SaMD Device, clearing a backlog of 681 complaints in Jira within two months of hire and increasing the complaint closure KPI from 40% to >95% YTD.
• Developed and managed all Post Market Surveillance processes including PMSRs, PMS Plans, and seven SOPs.
• Prepare and submit 510(k) and de Novo for NPD and SaMD devices along with reviewing ECOs for existing products.
• Executed 40+ user test cases (UAT) for software validation of software changes and data sources through SDLC.
• Led FDA and ISO 13485 audit preparation for post market surveillance, complaint handling, and CAPA modules.

Big Medical Device Company

Regulatory Affairs Program Manager Early 2022 – Late 2022

• Reviewed and drafted IFUs, SDS, CEP, CER, SSCP, PMCF, PMCFP, and DHF for neuromodulation and SaMD device.
• Led the development of regulatory responses for 150+ Competent Authority questions upon review of submissions.
• Executed 80+ MAUDE searches along with performing State of the Art (SOTA) literature searches using PubMed.
• Provided end-to-end oversight for three medical writers in new product development for a novel SaMD device.
• Maintained EU compliance for existing devices through remediation of CE Marking for EU MDR 2017/745.

Big Orthopedic Medical Device Company

Regulatory Affairs Specialist II Early 2021 – Early 2022

• Produced and maintained PMSRs, PSURs, and CERs for orthopedic and robotic (SaMD) product lines.
• Filed Adverse Event Reports (e.g., MDR, MIR) to domestic and international regulatory bodies via eSubmitter.
• Conducted in-depth analyses of 500+ complaints, adverse events, and sales data, leading to a 20% reduction in wrongful complaint code assignment by providing lessons learned to software, engineering, and business teams.
• Integrated R, RStudio, and SQL to automate PMS data retrieval leading to 2x efficiency in deliverable completion.

Consultant Work for Big Medical Device Companies

Regulatory Affairs Consultant Early 2019 – Early 2021

• Prepared and filed STEDs, IDE, 510(k), PMA, Design Dossiers, Declarations of Conformity, and CE Technical Files.
• Reviewed and approve ECO’s for supply chain, manufacturing, and or design changes for currently marketed products.
• Provided ROW regulatory strategy and regulatory impact assessment for SaMD, IVD, and orthopedic devices.
• Investigated 150+ complaints, reducing recurrence rates by 11% through Root Cause Analysis and CAPAs.
• Standardized 12 SOPs creating streamlined templates, reducing manufacturing nonconformance by nearly 30%.

EDUCATION
Regulatory Affairs Certificate Top CS School

Regulatory Affairs Certification (RAC) Regulatory Affairs Professional Society (RAPS)

Master of Business Administration (MBA) Top CS School

Bachelor of Science, Biochemistry & Molecular Biology Some Liberal Arts College

SKILLS & INDUSTRY KNOWLEDGE
Software: Trackwise, Master Control, Windchill PLM, Veeva Vault RIM, eSubmitter, SDLC, Python, R, Power BI, Tableau, SQL, Excel, Jira, Confluence, Asana, Agile, Kanban, Waterfall, Smartsheets, Documentum, SharePoint

Regulations: ISO 13485/14971, IEC 60601/62304, 21 CFR Part 803/820, EU MDR, FDA, Health Canada, IMDRF

I see some issues here.

You have had a new job almost every year. This would make some companies nervous that you would always be looking to leave for the next opportunity.

You are expecting a senior position when you have less than 5 years of experience and some of those years were pandemic years. Make sure you are meeting the minimum experience when applying for jobs.

You are claiming that you reduced nonconformances, recurring complaints, and other things by specific percentages. It feels like you are wanting to take credit for things that were clearly a team effort. Also, did you do that math, or did someone else?

You should correct disjointed statements. "Prepare and submit 510(k) and de Novo for NPD and SaMD devices along with reviewing ECOs for existing products." Could become three separate statements: One on 510k, one on De Novo, and one on ECO reviews.

I read your resume and I don't know some of these acronyms. Best to spell out the first instance of an acronym to avoid appearing pretentious.

Some statements are confusing, like this one: Provided end-to-end oversight for three medical writers in new product development for a novel SaMD device. What was being written? Did you write anything? What kind of oversight did you provide? Just watching over someone else producing something is not too impressive. What did you produce?

You are not highlighting your QA experience enough in my opinion.

Hope that helps.

If I am the recruiting person, I may not like just mentioning "7 SOPs."

Too technical, too detailed, too much will to jump to the next opportunity. Zero relevant experience, as each of the positions mentioned were way too short to be relevant. Apologies for being too direct and too honest.

I'm not in a position to hire, but the experience sounds fine for an individual contributor within a Regulatory Affairs department.

I would remove the specific numbers from test cases, complaints and database searches. Folks could hit those numbers in a week without trying, so they aren't impressive by themselves. YMMV, but to me it looks like it is sort of bragging at an incorrect scale. Those are important things to have done, but I wouldn't hire someone as a kitchen lead because they prepared 100+ meals.

I have a general sense that in-house regulatory affairs groups are shrinking, with a preference for out-sourcing. Maybe find one of those groups that people outsource to?

A previous employer (mid-sized developer/manufacturer) of mine essentially stopped listening to RA about 12 years ago because management literally didn't want to hear about the changing regulatory landscapes (stuff like "3rd edition won't affect us" and "REACH/RoHS is a fad"). As a result, that RA department ended up doing only pretty trivial support for a smaller and smaller set of design changes related to recalls and there is just about nobody left except the woman whose email is used for UDI contact.

I am in regulatory affairs (premarket) and often involved with reviewing candidates in the hiring process. I don't think your self assessment aligns with how hiring managers will see you, and I think the way you present your experience is likely not helping you if you're applying to a specialized role. Some of your really good experience is buried and is likely not registering with a reader.

5 years is not enough for a high level or manager level RA role. In my experience title levels are about 2-3 years apart (eg, Specialist/Senior Specialist/Staff/Senior Staff/Principal/etc...). "Principal" at most places would be at least 8-12 years experience. So immediately I think the level you're aiming for is unrealistic.

RA highly values internal knowledge and deep experience, especially in a high level decision making role. Your resume does not show a lot of consistency and doesn't show that you have deep knowledge in a particular area, which is what companies need in a manager or high level IC. If you are looking to move into a management role, you will be better off aiming to get in the door and build experience at a company, then move up into management.

Since you have a lot of different experiences, you should tailor your resume for each role to highlight the directly relevant experience. To second @Tidge 's comment- you are highlighting the numbers for the wrong stuff. For premarket regulatory the most important number is how many submissions you've completed. If you have impressive clearance time numbers you can reference that too. If you're applying to postmarket roles, highlight your postmarket experience and not submission work.

It's obvious that you do have experience and it's probably more interesting when it's not anonymized. From what you have here I would suggest you do a lot more tailoring for the specific roles you want, and aim at more of the 3-6 year experience IC range (maybe specialist/senior specialist).