Regulatory Affairs Specialist Job at ACE Partners, Austin, TX

OERVM0NWU25CSkd4ZVlnbGhBV1FqQ1E3NlE9PQ==
  • ACE Partners
  • Austin, TX

Job Description

Regulatory Affairs Specialist – Medical Devices - $80k - $100k

US Citizens or Green card holders only

No C2C

An innovative medical device company is looking for a Regulatory Affairs (RA) Specialist to join their team. This role focuses on developing regulatory strategies, preparing U.S. and international submissions, and ensuring compliance for life-saving cardiac and vascular products.

Key Responsibilities:

  • Define and execute regulatory strategies for submissions, including 510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian Licenses, and other international registrations .
  • Manage amendments, supplements, renewals, annual reports, and responses to regulatory agency inquiries.
  • Collaborate with global teams, regulatory partners, and cross-functional stakeholders to support regulatory approvals and market entry for new and existing products.
  • Review and provide regulatory guidance on labeling, promotional materials, product changes, and documentation to ensure compliance.
  • Maintain a deep understanding of global regulatory requirements and liaise with regulatory authorities as needed.
  • Support regulatory compliance activities such as facility site registrations, audits, CAPAs, NCRs, post-market surveillance, and risk management .
  • Develop and maintain regulatory processes, SOPs, and internal documentation to align with evolving global regulations.

Qualifications & Experience:

  • Bachelor’s degree with at least two years of regulatory experience , or an advanced degree with at least one year .
  • Experience with FDA Class II or III devices or EU Class IIb or III devices .
  • Strong ability to interpret and apply regulatory requirements in a medical device or life sciences environment .
  • Experience working in cross-functional teams with engineers, quality, and regulatory professionals.
  • Excellent technical writing, communication, and project management skills .
  • Ability to manage multiple regulatory projects simultaneously and meet tight deadlines.

Preferred:

  • Experience with Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices, or human tissue regulations .
  • Knowledge of global medical device regulations and submission pathways .

Job Tags

Similar Jobs

Zara

Visual Merchandiser Job at Zara

As a Visual Commercial you will primarily be responsible for executing the commercial strategy while maintaining an attractive image adapted to the client. You are interested in and learn about products, fashion trends and competitors in the local retail market. You have...

SRE Environmental

Class A Vacuum Tanker Truck Driver - Local / Regional (Work Hard/Be Rewarded) Job at SRE Environmental

SRE Environmental Job Title: Class A Vacuum Tanker Truck Driver - Local / Regional (Work Hard/Be Rewarded) If you are looking for a position where your hard work will be recognized and rewarded, this is the right place for you (make as much as $70,000 your first year... 

Bayforce

Oracle Integrations Developer Job at Bayforce

 ...We are seeking a highly skilled and experienced Integration Developer/Specialist to join our team. The ideal candidate will have 5-6 years of Oracle Integration Cloud (OIC) experience and a strong background in integrating various enterprise systems. This role requires... 

Once Upon A Child

Nights and Weekend Retail Associate Job at Once Upon A Child

 ...Nights and Weekend Shift Retail Sales Associate Canton, OH We are excited to invite enthusiastic and reliable retail associates to join our dynamic team! We are particularly looking for individuals who are eager and prefer working nights and weekends. If you thrive... 

AEC Resources

Electrical Design Engineer - Water Treatment Job at AEC Resources

 ...Electrical Design Engineer Water Treatment Are you an Electrical engineer that has experience with water and wastewater infrastructure? Reasons to Join Us: Unlimited Paid Time Off (PTO) Recharge When You Need It We know that top professionals do...