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Kelly Services, Inc.

Regulatory Affairs Manager (Medical Device)- Relocation available!

Kelly Services, Inc. - Highlands Ranch, CO



Job Description
Regulatory Affairs Manager (Medical Device) —Denver, CO\r
The Regulatory Affairs Manager will be responsible for managing all regulatory activities, including medical device product registrations and regulatory submissions for medical device product lines internationally. Reporting to the Director of Regulatory Affairs, this position supports all regulatory activities related to the launch of new products, maintenance of existing products, regulatory compliance, and regulatory systems for the company.\r
Essential Duties and Responsibilities:\r
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\tResponsible for the development of regulatory solutions to complex problems that affect diverse functional areas of the business or company.\r
\tProvides technical guidance and regulatory training/mentoring to other Regulatory Associates and cross functional teams.\r
\tCreate new methods, techniques, and processes across multiple job areas and functions, exerting some influence on the overall objectives and long-range goals of the company.\r
\tManages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.\r
\tRepresent specific business areas and geographies as the primary contact, interacting and creating an ongoing, proactive relationship with internal scientific, marketing, and engineering colleagues and regulatory authorities.\r
\tCoordinate activities with senior management team and responsible for overseeing regulatory compliance, development, and timely national and international regulatory submissions, ensuring that all regulatory activities are conducted with the highest integrity and in an ethical manner.\r
\tReviews staff submissions to identify adequacy of sections, completeness, and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed.\r
\tRepresent departmental functions, acting as primary interface with regulators, presenting strategies and negotiating solutions, and lead intra- and inter-company projects.\r
\tInterprets, executes, and recommends modifications to operating policies at business level. Will establish operating policies within specific business operating areas and recommend policies that impact other areas.\r
\tShares experience with most stages of product life cycle and concentrates on new product development and post-market applications of existing products.\r
\tCommunicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies to achieve timelines.\r
\tEnsures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims.\r
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Job Requirements:\r
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\tBachelor’s degree in physical/biological sciences or engineering\r
\tMinimum 10 years of experience in Regulatory Affairs and at least 3 years direct management experience preferred\r
\tSoftware as medical device experience (SAMD, MDDS, High Level of Concern Software) with Regulatory Affairs Certification (RAC) strongly desired\r
\tDirect experience in gaining FDA or Notified Body approvals for devices or drugs or biologics\r
\tDemonstrated success in the management of regulatory submissions such as CE Mark for Class II-III products, IDE’s, IND’s, PMAs, 510(k)’s, NDA’s, ANDA’s\r
\tKnowledge of technical aspects of regulatory profession, combined with scientific understanding and project management skills\r
\tUnderstands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges and ability to resolve them through collaboration\r
\tRecognized as an emerging authority within the business or function with broad understanding of and experience working with multiple functions that are unrelated\r
\tExpert with Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures\r
\tPossess business insight and have ability to understand how product approval strategy interacts with business strategy, may involve in creating/ proposing such strategy\r
\tNimble learning and able to actively seek out relevant legislation and competitive information on product lines\r
\tMust be results oriented and decisive. Failure to obtain results or arrive at appropriate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.\r
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Apply Today!  Questions?  Call Justin at 714.971.0721 or send your resume to Justin.lynn@kellyscientific.com\r

Why Kelly®?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About
Kelly 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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Kelly Services, Inc.

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Regulatory Affairs Manager (Medical Device)- Relocation available! Kelly Services, Inc. - Highlands Ranch, CO, United States

   

Location: Highlands Ranch, CO

Company Profile:
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company. Established in the International Marketplace In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations. Total Sales Revenue in 2016 was $5.3 billion. Fortune U.S. Rank Kelly Services is currently ranked 490 in the Fortune 500 list of America’s largest companies.