Director, Regulatory Affairs at Smiths-Medical in Minneapolis, Minnesota

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DIRECTOR, REGULATORY AFFAIRS

Location
North America, USA, Minnesota, Minneapolis

Job Reference
MEDNA01047

Job Function
Reg Affairs & Quality Assurance

Job Description

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

The Director of Regulatory Affairs will be responsible for the development and execution of the global regulatory product strategy. This position will develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions. This role will also provide regulatory expertise and guidance to product teams.

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

* Representing regulatory on the product teams and other key commercialization governance bodies, including the Business Unit Enterprise Boards

* Leading regulatory team(s)

* Develop Global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan. Represent Regulatory on product teams to ensure development of product registration strategies and development plans aimed at achieving regulatory approval

* Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance

* Lead the planning and implementing global regulatory filings

* Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)

* Monitor and assess impact of relevant global regulations, guidance s, and current regulatory environment

* Ensure guidance on regulatory mechanisms to optimize product development are assessed and incorporated into the global regulatory strategy

* Consistently communicate well defined, successful regulatory strategies throughout the organization such that expectation is understood

* Produce strategies that provide innovative alternatives which communicate the associated risks

* Communicate Smiths Medical s position consistently cross-functionally and across all documents

* Develop the ability to articulate and educate the likelihood of regulatory success based on proposed strategies

* Develop ability to accurately predict expectations and outcomes by regulatory agencies

* Direct global regulatory agency interaction strategies, in collaboration with regional colleagues

* Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)

* Attend key regulatory agency meetings which could impact the global product strategy

* Lead GRT to develop and execute team goals

* Integrate regional regulatory representative input into GRT and regulatory plans

* Represent GRA on key commercialization teams

* Represent GRA on external partnership teams at the product team level

* Provide education and training on regulatory strategies and compliance issues to other functions

* Ensure regulatory compliance for product Regulatory oversight and intelligence across the US, EU and other mature markets.

* Coordinate close liaison through our trade association relationships with AdvaMed, EUCOMED, ABHI and MDMA so that Smiths Medical can keep close to changes, and also participate in trade association committees in crafting the future regulatory landscape .Keep abreast of new and changing regulatory requirements.

* Advise and/or Update RA Corporate Policies and SOPs as needed to ensure Smiths Medical is in compliance with new and changing 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, Bachelor's degree in Science or Engineering (or related field) from an accredited college or university preferred.

* Minimum of 10 (ten) years of management experience in regulatory affairs (preferably in the medical device/drug or biomedical area).

* Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, Canada, TGA, PAL, Medical Device Directive, and European Standards.

* Excellent working knowledge of regulatory requirements to distribute drugs in the US; FDA, DEA, and state regulations and statutes.

* Sound knowledge and understanding of company products as they relate to medical device and drug law and international medical device requirements.

* Effective facilitation skills to motivate multifunctional groups; engineers, marketing, sales, QA, RA, R&D, and OUS personnel to deliver compliance projects on- time, to budget, and with quality of work.

* Proven effective leadership skills to guide, mentor, and develop staff members to perform under stress to meet or exceed project schedules and corporate filing deadlines.

* Excellent interpersonal skills to interface with all levels of company structure as well as represent company to outside agencies.

* Excellent verbal, written, and presentation communication skills.

* Ability to review and approve corporate Divisional SOP's and to establish procedures.

* Ability to negotiate critical points regarding compliance matters to the favor of corporate objectives, (i.e.

At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world s healthcare markets.

Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for supporting managing chronic illness.

Smiths Medical is an EEO/AA Employer/Vet/Disabled

If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).

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