Compliance Specialist II

Compliance Specialist II

Location

North America, USA, Minnesota, Minneapolis

Job Reference

MEDNA01583

Job Function

Reg Affairs & Quality Assurance

Job Description

Smiths Medical is currently hiring a Compliance Specialist II in Minneapolis, MN.

The Compliance Specialist II will support the oversight of Smiths Medical compliance programs to ensure that activities occurs in a timely manner, including administration of the systems, training others within the organization on techniques used with the systems and coaching and providing adequate assistance to internal customers of the system. This role is also responsible for ensuring the organization is operating in compliance with Quality Policies, Standard Operating Procedures, GMP and other applicable regulations

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

* Conducts project work as required by the Director of Global Compliance to complete team activities and achieve team objectives. May perform additional related duties as assigned. This position will support the Management Team in the assure of Company operations compliance 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).
* May be involved in Field Action and Recall Management. Works with teams to develop field corrective action and recall plans. Assists with execution and reconciliation of field corrective actions and recalls. Assists with developing and preparing correspondence to external government agencies and external customers. Works with the Global Compliance Manager to ensure Global Field Action program health by providing metrics and reporting. Works with the Global Compliance Manager to identify and implement process improvements in the Global Field Action program.
* May be involved in support of CAPA Management. Works with the Global CAPA Manager to assist in the strategic oversight of CAPA programs at each Smiths Medical site, ensuring Global CAPA program health by providing metrics and reporting to Smiths Medical leaders and identifying and implementing process improvements in the Global CAPA system. Supports functional teams to perform CAPA investigations, including use of industry recognized root cause analysis tools. Provides coaching and mentoring to CAPA owners to ensure CAPAs are compliant with regulations and internal procedures as required. Manages multiple priorities either independently or as part of a team in order to meet key department deadlines and communicate issues and progress. Participates in the identification and implementation of process improvements in the Global CAPA system. Completes quality assessment of CAPA records to ensure compliance with procedures as required. Supports the department manager in preparing and presenting data for internal and external audits
* May be involved in Government Communication and Audit related activities. Researches and prepares correspondence in response to external government agencies. Reviews corrective action plans for internal and external audit responses, ensuring the responses satisfy company and regulatory requirements. Performs audits and assessments against company and regulatory requirements.
* 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

* University Degree (BA degree) required.
* Two (2) to Four (4) years of direct experience in Medical Device Quality or Compliance (multi-site Medical Device organization experience preferred.
* Excellent working knowledge of current, international, and company regulatory compliance requirements and operating procedures, including (but not limited to) FDA, PMAA, European Medical Device Directive and Medical Device Regulation, and applicable industry Standards.
* Demonstrated proficiency at critically reviewing quality documentation (e.g. procedures).
* Effective facilitation skills to motivate cross-functional teams to meet objectives (for example, execution of field actions/recalls) within expected time-frame.
* Proficient computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, graphics, etc.
* Excellent verbal, written, and presentation communication skills. High attention to detail.
* 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.