Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 47 days ago

Alltrista - Director, Quality Systems & Regulatory Affairs

jadex27 open roles

Where
Greer, SC, USA
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowAlltrista - Director, Quality Systems & Regulatory Affairsjadex · Greer, SC, USA

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on jadex's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 47 days ago

The posting

The Director of Quality Systems and Regulatory Affairs will be responsible for ensuring compliance with regulatory requirements, maintaining robust quality management systems, and guiding product development processes across the organization. This role requires a strategic leader who can navigate complex regulations and drive a culture of quality excellence.   Primary Functions

Develop and implement quality and regulatory strategies aligned with corporate objectives and regulatory requirements. Lead and mentor the Quality Systems and Regulatory Affairs team, fostering a culture of compliance, continuous improvement, and accountability. Serve as the primary point of contact for all regulatory agencies and manage communications regarding submissions, inspections, and inquiries. Prepare and submit necessary regulatory filings (e.g., 510(k), PMA, CE Mark) to obtain and maintain product approvals across global markets. Oversee the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA regulations, and other relevant standards. Conduct regular audits and inspections to ensure compliance with quality system requirements and proactively address non-conformities. Lead risk management activities throughout the product lifecycle, including risk assessments, mitigation strategies, and post-market surveillance. Ensure that product-related complaints are investigated and resolved in a timely manner, with appropriate reporting to regulatory authorities. Develop and execute training programs for employees regarding quality standards, regulatory requirements, and best practices. Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure compliance throughout all phases of product development and commercialization. Drive initiatives for continuous improvement in quality processes, metrics, and product quality outcomes. Analyze data to identify trends, make informed decisions, and generate reports for leadership review.

Key Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related field; Master’s degree preferred. A minimum of 10 years experience in Quality Assurance and Regulatory Affairs within the medical device industry. In-depth knowledge of FDA regulations, ISO standards, and other international regulatory requirements applicable to medical devices. Proven experience in leading regulatory submissions and quality system audits.

Strong leadership, communication, and interpersonal skills. Ability to work collaboratively in a team-oriented environment and manage multiple projects simultaneously. Demonstrated ability to influence across functions and lead through collaboration rather than direct authority. Strong analytical, communication, and leadership skills. Experience supporting senior leadership and driving business performance through financial insights.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against jadex's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on jadex's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    jadex's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.