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

Open nowFirst seen 2 days ago

Sr. Regulatory Affairs Specialist

TECOMET66 open roles

Where
Warsaw, IN, USA
Get the CV for this job

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

Your applicationOpen nowSr. Regulatory Affairs SpecialistTECOMET · Warsaw, IN, 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 TECOMET'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.

12.1% of postings close within 7 days. Measured by our own scanner across the market. TECOMET postings stay open a median of 2 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.1%7 days
  4. 19.1%14 days
  5. 35.6%30 days
  6. 52.7%60 days
This job: first seen 2 days ago

TECOMET median: 2 days open

The posting

Sr. Regulatory Affairs Specialist

Position Summary

The Sr. Regulatory Affairs Specialist will be Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Ensuring that the company adheres to all relevant laws, regulations, and standards. The position requires good knowledge of industry regulations and effective communication skills to guide and inform various stakeholders. The Regulatory Engineer will ensure that the regulatory-related requirements from our customers are communicated clearly and concisely to all employees to ensure that the company meets domestic and international customer and governmental regulatory requirements. The Sr. Regulatory Affairs Specialist assists in teaching regulatory requirements and best practices to team members. Conduct 1st and second party audits to assess adherence to the QMS and domestic as well as international regulations.

This accomplished by maintaining Tecomet principles of Safety, Quality, Customer Satisfaction and Innovations.

Principle Responsibilities

  • Field complaint investigations and reporting
  • Perform regulatory reviews of Tecomet standard product and customer co-development design files to approve for release
  • Collaborate with other departments to address compliance issues
  • Provide training and support to staff on compliance matters
  • Act as a liaison between the company and regulatory bodies
  • Investigate and resolve compliance violations
  • Stay updated with changes in regulatory landscape and industry standards
  • Advise senior management on compliance risks and mitigation strategies
  • Maintain current knowledge of relevant regulations
  • Create Declarations of Conformities for release
  • Regulatory reviews of memos to file
  • ODCR reviews
  • Participate in ISO audits and Technical File Reviews
  • Annual review of all Tecomet products (PMS)
  • Manage domestic/international medical device distribution submissions
  • Participate in design reviews
  • Maintain FDA MDL listings/submissions for Tecomet and Customer products
  • Create and submit Certificates to Foreign Government for Tecomet products
  • Participate in ISO audits and Technical File Reviews
  • Conduct First and Second Party Audits to Regulatory Standards
  • Effectively document clear and concise audit reports and findings
  • Evaluate corrective action in response to observations made throughout audit process
  • Annual review of all Tecomet products (PMS)
  • Additional functions and requirements may be assigned by manager as deemed appropriate

Qualification Requirements

Credentials/Experience:

  • Working knowledge of government(s), international, and national regulations regarding medical devices (i.e. FDA, MDD, CMDCAS, PAL, ISO etc.)
  • Minimum Four years of experience in a quality and regulatory related field or equivalent combination of education and experience.

Experience/Educational/Training Preferred:

  • Bachelor of Science Degree Preferred.

Knowledge, Skills, and Abilities:

  • Ability to read, analyze, and interpret technical journals, technical procedures, and/or government procedures
  • Ability to respond to common inquiries or complaints from customers, or regulatory agencies
  • Ability to define problems, collect data, establish facts, and interpret technical instructions to draw valid conclusions
  • Ability to handle multiple projects simultaneously
  • Effective organizational skills
  • Computer skills – Proficient in MS Word, Excel, and PowerPoint
  • Familiarity with risk management and mitigation
  • Manufacturing-related knowledge of medical devices to effectively conduct strategic process adequacy risk assessments
  • Team-oriented attitude
  • Ability to work in a proactive and reactive environment
  • Ability to deal with complex and difficult situations unsupervised
  • Ability to maintain confidentiality of information

Other Requirements

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.

Travel Requirements

Up to 10%

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 TECOMET'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 TECOMET'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

    TECOMET'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.