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Regulatory Affairs Manager

Employer
Smiths Medical
Location
Minneapolis
Salary
Competitive

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Regulatory Affairs Manager

Location

North America, USA, Minnesota, Minneapolis

Job Reference

MEDNA01480

Job Function

Reg Affairs & Quality Assurance

Job Description

Smiths Medical is currently hiring a Regulatory Affairs Manager in Minneapolis, MN.

The Regulatory Affairs Manager will provide regulatory expertise for the site and manage the work activities of the RA team. Incumbent will provide regulatory advice and assistance to other Smiths Medical site representatives. This role will develop and prepare regulatory submissions, i.e., 510(k) Premarket Notification, PMA, IDE, Design Dossier, and CE Technical Files, while also reviewing and ensuring regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects. Additionally, this position will prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date, and also develop regulatory strategy and departmental positioning. This position will participate as the regulatory representative on project teams, communicate regulatory requirements and strategy, while preparing and conducting meetings/teleconferences with external regulatory agencies as assigned.

We are seeking a strong and experienced medical device program management professional to lead programs with components of both major quality system and technical product improvements. Solid background in medical device regulations (FDA QSR, ISO 13485) and/or medical device product development processes is required. This role will be high-visibility and partner with leadership to drive widespread change through the organization.

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

* Manage work activities of the RA team.
* Ensure RA work activities are in line with overall project requirements and schedules. Monitor closely project activities ensuring RA team members have adequate resources to complete submission activities. Readjust work activities as needed.
* Approve PTO consistent with requirements of overall project schedule requirements.
* Conduct performance reviews of employees. Develop in conjunction with employee development plans. Collaborate with manager when finalizing employee development plans.
* Conduct interviews and make hiring decisions for positions within RA Department.
* Coordinate department activities consistent with overall business and project activities ensuring adequate RA resources are available and prioritized with these activities. Escalates conflicting needs of the business to manager for resolution.
* Prepare and maintain regulatory submissions and files as required.
* Prepare 510(k) Premarket Notification, PMAA, IDE, DMF, MAF, Design Dossier submissions as directed.
* Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking.
* Prepare and maintain communication to government regulatory agencies and notified bodies as needed.
* Review and coordinate preparation of Pre-launch checklists for new and existing products to ensure compliance with internal company requirements and compliance with regulatory requirements. Work with project teams to ensure information is complete and follow-up as needed.
* Assist Corporate Registration Unit as necessary to ensure information regarding products is readily available to unit personnel. Provide assistance and direction as needed.
* Maintain all regulatory files ensuring documentation, registers, directories and lists are complete and up-to-date.
* Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects.
* Review, edit and approve label reviews.
* Review, edit and approve operational engineering documentation (i.e. ECO review).
* 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.
* Seven to ten years related experience in regulatory affairs (preferably in the medical device or biomedical area).
* RAPS Professional Certification (RAC) preferred.
* Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, Medical Device Directive, and European Standards.
* Sound knowledge and understanding of how IDE regulated clinical studies are performed.
* Sound knowledge and understanding of company products as they relate to medical device law and international medical device requirements.
* Effective facilitation skills to motivate engineers, marketing personnel and/or clinical staff to deliver information related to submission or clinical protocol preparation.
* Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.
* Excellent verbal, written, and presentation communication skills.
* 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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