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Senior Principal Regulatory Affairs Specialist

Employer
Smiths Group plc
Location
Minneapolis
Salary
Competitive

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Industry
Government and Public Services
Role
Other
Job Type
Long-Term
Hours
Full Time
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Job Description

Smiths Medical is currently hiring a Senior Principal Regulatory Affairs Specialist in Minneapolis, MN.

The Senior Principal Regulatory Affairs Specialist will perform advanced regulatory work requiring recognized expertise in all aspects of regulation, guidance, standards and compliance expectations. This position will be responsible for exploring and recommending innovative, creative and complex technology for use in Smiths Medical product development and market authorization support. This position will also apply advanced theories, concepts, principles, and processes in assigned area of responsibility, while revising new approaches to non-routine problems as encountered.

Smiths Medical has a positive impact on someone's life around the world every minute of every day. In fact, over 240 people every minute benefit from a Smiths Medical product. Join us and grow your career while being a part of our continued success! We offer a fun, fast-paced, inspiring and collaborative work environment with opportunities to learn and contribute at all career levels. Innovation is part of who we are, with industry-leading products across a broad spectrum of medical device categories and a strong new product development pipeline.

Duties & Responsibilities

  • Provides technical leadership on major programs and provides guidance and direction to the regulatory team. Sets goals/deadlines and adhering to them, holding teams accountable for meeting deadlines to drive results.
  • Develops and conducts Smiths Medical facilitated training and development programs for internal departments designed to increase knowledge in issues related to regulatory.
  • Provides innovative approaches to problem resolution. Represents Smiths Medical, Inc. with customer groups and technical forums such as MDMA and MedTech Europe.
  • No direct subordinates; provides functional supervision to the regulatory team and acts as a recognized leader and authority in the regulatory area.
  • Provides strategic leadership, technical advice and direction to other members of the regulatory team. Drives the decision-making process, conducts meetings, and makes presentations for assigned projects. Oversees the preparation of documentation associated with regulatory submissions including 510(k)s, annual reports, Technical Files and Design Dossiers.
  • Responsible for ensuring the right frequency of communications within and outside of department in support of regulatory activities, such as project management meetings, project review, etc.
  • Establishes and maintain relationships with key individuals and contributors within the regulatory governing community and specifically within agencies in markets we participate in.
  • Work requires the expert application of advanced and innovative regulatory strategies for support of global market authorizations.
  • Oversees regulatory submission strategy development and activities of major significance, which are highly difficult and complex in nature.
  • Plans and assigns work to the regulatory team (tasks and responsibilities; assists in the evaluation of personnel performance.
  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

    • Diversity & Inclusion

    We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.

    The Individual

  • Scientific University Degree (BS Degree) required.
  • Advance degree preferred.
  • 18+ years of experience.
  • Software / SAMD, Cybersecurity, familiarity with IEC 60601-1, infusion experience a plus
  • Ability to plan and conduct effective meetings and group presentations.
  • Ability to operate with wide latitude autonomous action or decisions.
  • Ability and willingness to lead and create change - changes in policy, procedure, technology and culture.
  • Ability to coach and mentor others in technical matters.
  • Ability to clearly convey ideas and concepts verbally and in writing.
  • Ability to handle multiple priorities and to meet key deadlines under pressure through effective time management skills.
  • Ability to work accurately with attention to detail.
  • Ability to critically review and interpret technical documentation.
  • Advanced problem solving and analytical ability.
  • Ability to work with integrity and build trust.
  • Proven ability to lead, establish, maintain and influence effective working relationships with internal customers within the region and across functions.
  • Strong influencing ability and ability to provide functional supervisor to the regulatory team as required.
  • Education requirements can be obtained through an educational institution or gained through equivalent work experience.

    • Salary & Benefits

    In addition to a competitive compensation package, Smiths Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more!

    About Smiths

    At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 23,000 colleagues, based in 55 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers' operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field.

    About Smiths Medical

    Smiths Medical is always looking for people with a passion to positively impact the health and wellbeing of people around the world. If you have a curious mind, relish a challenge and want to make a difference then bring your talents here and your opportunities are endless. We're proud that we've been helping propel the human world forwards during our 160-year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big we have introduced some of the most trusted brand names in healthcare. Today we're an aligned global business 8,000 colleagues, that touches the lives of 7 people every second across the globe. So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future.

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