**_Regulatory Manager, Andover, MN_**







Kelly Services is currently seeking a Regulatory Manager for one of our top clients in Andover, MN to ensure products are certified and compliant. Our well-respected client is one of the largest of its kind in the world! In this high visibility role within the company you will be responsible for providing Regulatory leadership to development teams. This includes global regulatory strategies and cross functional alignment with issues of possible Regulatory ramifications and mentoring junior regulatory staff.







**Role and Responsibilities**










+ Manages the Regulatory Affairs function


+ Develops global regulatory strategies


+ Ensure compliance to 231 CFR 820, ISO 13485, MDD/MDR, MDSAP, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.


+ Provides Regulatory leadership to development teams, e.g., global regulatory strategies and cross functional alignment with issues of possible Regulatory ramifications and mentoring junior regulatory staff.


+ Acts as a liaison with Quality, R&D, Legal, and Operations.


+ Provides technical guidance and training to staff


+ Responsible for submission preparation and development of labeling, marketing or promotional materials, training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.


+ Prepares submissions for device design changes and /or manufacturing changes.


+ Reviews product and manufacturing changes for compliance with applicable regulations (Change Control).


+ Reviews protocols and reports to support regulatory compliance and submissions.


+ Reviews device labeling and advertising materials for compliance with applicable regulations.


+ Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).














**Qualifications**










+ Bachelor?s degree (BS, BA) (technical discipline preferred) with at least 5 years? Medical device and 2 years of regulatory experience.


+ Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.


+ Ability to work effectively within a team in a fast-paced changing environment.


+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.


+ Ability to travel approximately 10%, including international








Engineering Manager -













**Why Kelly** **?** **?**






Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.









**AboutKelly Services** **?**







As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .





Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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