Veran^® Careers

We’re looking for a Regulatory Engineer – Level II to assist in timely completion of all worldwide regulatory activities relating to product compliance, marketing clearance and certification of FDA Class II medical devices. Prepare and/or facilitate 510(k) submissions, Letters to File, Technical Files, CB Reports and technical construction files. Support compliance of all existing and new products to domestic and international regulations and standards including, but not limited to EU MDR, IEC and ANSI/AAMI. Support compliance of the Quality System to the requirements of FDA’s Quality System Regulation, ISO 13485, ISO 14971 and related standards. Support proper implementation and use of established QA/RA policies and processes

Location: St. Louis, MO
Listing Date: October 10, 2019
Position: Regulatory Engineer – Level II
Job Type: Full-Time
Education: Bachelor’s degree preferred OR demonstrated equivalent experience
Direct Report: Director of Quality Assurance and Regulatory Affairs

Responsibilities:

• Coordinate product marketing clearance and certification activities with respect to planning, scheduling and submitting regulatory documents (e.g. – 510(k)s, letters to file, product licenses) based upon a thorough knowledge of FDA regulations, guidance documents and international licensing requirements
• Represent regulatory affairs and assure proactive relationship in various cross-functional meetings and project teams with engineering, operations, marketing, quality and clinical affairs to ensure that all products are and remain in compliance
• Review and approve product and process change orders to ensure regulatory and standards compliance
• Review and approve product labeling to ensure accuracy in supportability of claims and to ensure fulfillment of product labeling requirements
• Prepare regulatory filings as appropriate
• Prepare and submit adverse events as appropriate to affected regulatory bodies
• Perform risk management activities per ISO 14971 and participate in product risk analysis activities
• Perform internal regulatory audits to verify compliance of products with applicable safety standards and technical construction reports
• Participate in product design reviews to identify potential design issues and to assist project teams with design solutions
• Other tasks as assigned

Qualifications:

• Bachelor’s degree preferred OR demonstrated equivalent experience
• 5 to 8 years of relevant medical device industry experience, preferred in Regulatory Engineering
• RAPS Regulatory Affairs Certification preferred, but not mandatory
• Knowledge of ISO 13485:2016, FDA Quality System Regulation, MDR knowledge preferred
• Good record-keeping and attention to detail
• Proficient in product & process development concepts, including change control, design verification and validation and risk management
• Problem solving abilities for medical device and process improvements
• Excellent written and verbal communication skills, including ability to communicate technical information
• Good recordkeeping and attention to detail
• Experience in medical device submissions for 510(k), CE certification, etc. preferred
• Ability to read, write and speak English
• Proficient in product & process development concepts, including change control, design verification and validation and risk management
• Organizational skills, detail oriented, trustworthy

The Regional Manager, Utilization Sales is responsible for acquiring full knowledge of the operation, potential capabilities, and value propositions for the Veran SPiN Thoracic Navigation System™ and ig4 platforms. Additionally, they are responsible for meeting sales quotas for disposable products, and for driving system utilization in their assigned territories.

The right candidate will have previous experience being accountable for reaching specific sales targets, and be able to grow product utilization within our current customer base. Additionally, our ideal candidate will combine excellent communication skills with a strategic mindset, and possess the drive to ensure their area of responsibility meets or exceeds the expectations of our business objectives.

To apply, submit your resumé in PDF format.

Location: Denver, CO
Listing Date: October 19, 2020
Position: Regional Manager, Utilization Sales
Job Type: Full-Time
Education: Bachelor's Degree or Equivalent Education/Experience
Direct Report: Area Vice President of Sales (AVP)

The Regional Manager, Utilization Sales is responsible for acquiring full knowledge of the operation, potential capabilities, and value propositions for the Veran SPiN Thoracic Navigation System™ and ig4 platforms. Additionally, they are responsible for meeting sales quotas for disposable products, and for driving system utilization in their assigned territories.

The right candidate will have previous experience being accountable for reaching specific sales targets, and be able to grow product utilization within our current customer base. Additionally, our ideal candidate will combine excellent communication skills with a strategic mindset, and possess the drive to ensure their area of responsibility meets or exceeds the expectations of our business objectives.

To apply, submit your resumé in PDF format.

The Regional Manager, Utilization Sales is responsible for acquiring full knowledge of the operation, potential capabilities, and value propositions for the Veran SPiN Thoracic Navigation System™ and ig4 platforms. Additionally, they are responsible for meeting sales quotas for disposable products, and for driving system utilization in their assigned territories.

The right candidate will have previous experience being accountable for reaching specific sales targets, and be able to grow product utilization within our current customer base. Additionally, our ideal candidate will combine excellent communication skills with a strategic mindset, and possess the drive to ensure their area of responsibility meets or exceeds the expectations of our business objectives.

To apply, submit your resumé in PDF format.

Location: Indianapolis, IN
Listing Date: October 12, 2020
Position: Regional Manager, Utilization Sales
Job Type: Full-Time
Education: Bachelor's Degree or Equivalent Education/Experience
Direct Report: Area Vice President of Sales (AVP)

The Regional Manager, Utilization Sales is responsible for acquiring full knowledge of the operation, potential capabilities, and value propositions for the Veran SPiN Thoracic Navigation System™ and ig4 platforms. Additionally, they are responsible for meeting sales quotas for disposable products, and for driving system utilization in their assigned territories.

The right candidate will have previous experience being accountable for reaching specific sales targets, and be able to grow product utilization within our current customer base. Additionally, our ideal candidate will combine excellent communication skills with a strategic mindset, and possess the drive to ensure their area of responsibility meets or exceeds the expectations of our business objectives.

To apply, submit your resumé in PDF format.