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Director Regulatory Labeling Jobs in Minnesota (NOW HIRING)

Collabera

Labeling Specialist

Moundsview, MN · On-site

... direct placement services to global 2000 corporations. For consultants and employees, Collabera ... This position will be a subject matter expert in Medical Device labeling regulations and standards.

VDyne

Regulatory Affairs Specialist

Maple Grove, MN · On-site

... design, labeling, manufacturing, and process changes and prepare supporting regulatory ... of direct Regulatory Affairs experience with Class III and/or implantable medical devices · ...

Collabera

Labeling Specialist

Moundsview, MN · On-site

... direct placement services to global 2000 corporations. For consultants and employees, Collabera ... This position will be a subject matter expert in Medical Device labeling regulations and standards.

Danaher

Staff Global Regulatory GPO

Chaska, MN · On-site +1

... labeling requirements and marketing material review and approval procedures. This position reports to the Director of Global Compliance and Regulatory Affairs and is part of the Global Regulatory ...

Danaher

Staff Global Regulatory GPO

Chaska, MN · On-site

... labeling requirements and marketing material review and approval procedures. This position reports to the Director of Global Compliance and Regulatory Affairs and is part of the Global Regulatory ...

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Senior Regulatory Affairs Specialist

Saluda Medical

Minneapolis, MN • On-site

$125 - $150/hr

Other

Posted 9 days ago

Key responsibilities

  • Prepare submissions for regulatory authorities.

  • Liaise with regulatory authorities for applications under review, and coordinate responses to queries.

  • Maintain product and site licenses, registrations, certificates, and listings.

Job description

Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real‑time neurophysiological feedback.

SaludaMedical’sfirst product, the Evoke® System, is designed to deliver known,consistent,and personalized spinal cord stimulation therapy by objectively measuring neural responses andmaintainingtherapy within a prescribed therapeutic window.Saluda Medical is headquartered in Minneapolis, Minnesota.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives.

Reporting to the Sr. Director, Regulatory Affairs, the Senior Regulatory Affairs Specialist will provide input to global regulatory strategies and support submission activities for Saluda Medical’s product portfolio.

What You'll Do:
  • Prepare submissions for regulatory authorities
  • Liaise with regulatory authorities for applications under review, and coordinate responses to queries
  • Maintain product and site licenses, registrations, certificates, and listings
  • Work closely with the Product Development team, providing regulatory guidance and input into the design of new products
  • Assess proposed design, quality, and production changes to determine regulatory submission strategies
  • Review technical documentation for accuracy and completeness to support regulatory submissions
  • Monitor and review updates to regulations, standards, and guidance documents to ensure ongoing compliance to regulatory requirements
  • Assist with development of labelling content and review for compliance prior to release
  • Assist in the review of advertising and promotional materials in accordance with national regulatory requirements
  • Provide mentorship for junior RA Specialists and interns
What You'll Bring:
  • Tertiary qualification in a science or engineering related discipline (e.g. software, biomedical, mechanical)
  • Experience in medical device or other therapeutic goods industry, preferably in regulatory affairs
  • Broad understanding of medical device regulations and relevant ISO standards associated with the product development and approval process
  • Demonstrated experience in the management, compilation, submission, and maintenance of regulatory filings
  • Proven experience working with cross functional teams in a commercial environment
  • Strong written and verbal communication skills
  • Effective time management and the ability to work autonomously
  • Self-motivated team player, with a high level of personal integrity
  • Demonstrated analytical skills and strong attention to detail to identify and
  • resolve problems
  • A strong desire to contribute to the growth of the company
Desirable Requirements:
  • Experience with European, US and/or Australian Medical Device Regulations
  • Experience with Active Implantable and/or Class III medical devices
  • Experience with Australian reimbursement requirements
Our Core Values:
  • People – Our first responsibility is to the patients we serve.
  • Integrity – Do the right thing
  • Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo
  • Performance – Win together – Deliver with Excellence.

Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation.

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