Regulatory Affairs Manager

Medtronic. Careers with a passion for life.
As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. Everything we do is deeply rooted in our mission—to alleviate pain, restore health, and extend life. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for seven of the last nine years by Fortune magazine as one of the "100 Best Companies to Work For in America." Work with the kind of people who not only love what they do but why they do it.

Regulatory Affairs Manager
Santa Rosa, California

The position will focus primarily on the creation, preparation, and achievement of regulatory submissions and approvals to introduce new products in the US, EU, Japan, and other markets. Implement regulatory strategies and company initiatives. Internal Responsibilities Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), IDE, PMA(S), Design Dossiers, Device License Applications, Shonins, and internal “Letters to File”. Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings. Submit U.S. and international regulatory applications including 510(k)'s, IDE's, PMA's, Design Dossier's, Shonins, and Device License Applications.

Responsibilities: Develop detailed strategies for regulatory approval of medical devices. Responsible for foreign registrations and “Permission to Export” documents. Maintain submission correspondence files and other regulatory files in a complete and secure manner. Review and approve design and manufacturing changes, labeling, web page content, and advertisements. Create project deliverables aligned with appropriate internal and external guidance documents. Maintain annual facility registration and device-listing documents. Provide regulatory input in quality system assessments, product development, non-conforming material evaluations and complaint/MDR/Vigilance as well as other post marketing surveillance systems. Review and approve test protocols and reports to support regulatory submissions. Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes. Review and sign off on product and manufacturing changes and shipping release documentation for compliance with applicable regulations.

Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions, corrective and preventative actions, and review of proposed device changes. Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams. Provide project, department, and company guidance and training based on current and emerging regulatory affairs requirements, regulations, and processes, and focus on improved regulatory efficiency and effectiveness. Support the Medtronic Vascular Quality Policy and Quality System. Act as Regulatory lead on manufacturing and development teams, providing Regulatory Affairs feedback and guidance on regulatory inputs needed for global submission requirements.

Initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, under direction of supervisor, up to and including travel to, and direct discussions with the appropriate regulatory agency. Develop and deliver presentations to global regulatory agencies. Act as company representative, developing and maintaining positive relationship with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.

Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits. Participate in department systems development initiatives. Participate in training and mentoring of staff.

Other duties as assigned.
REQUIREMENTS
KNOWLEDGE/EDUCATION
• Bachelor’s degree.
• In depth knowledge of FDA medical device regulations.
• Thorough knowledge of European Medical Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.)
• Working knowledge of FDA medical device regulations, guidance, and exports requirements.
• Thorough knowledge of Canadian and Japanese Medical Device Regulations.
• Familiar with medical device labeling and promotional requirements.
• Familiar with FDA “paperless submission” (CD-ROM) approach.
• Knowledge of GLP/GCP requirements.
• Solid understanding and application of business concepts, procedures and practices.
• Solid understanding of US and EU labeling and requirements.
JOB EXPERIENCE
• 6 – 9 years of related work experience with a strong understanding of regulatory functional area.
• Experience with medical devices, PMA submissions, and Class III CE mark design dossiers.
• Successful original 510(k), IDE, and PMA(S) submissions.
• Successful original Design Dossier and Shonin submissions.
• Experience with regulatory support of clinical trials.

SKILLS/COMPETENCIES
• Proficient in timely review of technical and clinical data.
• Proficient in FDA and international regulations (EU and Japanese)
• Technical knowledge of medical devices.
• Ability to write clear, concise, and well thought out technical documents.
• Good presentation skills.
• Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills, with general supervision
• Strong Internet skill set.
• Computer skills; MS Word, PowerPoint, Visio, MS Project, Adobe Acrobat, Excel, database, graphics presentation applications, document processing/publishing tools.
• Strong organizational and interpersonal skills
• Strong written and oral communications skills
• Detail oriented
• Self motivated
• Able to actively contribute as a strong team member of team leader.
• Ability to exercise judgment in selecting innovative, practical methods to achieve problem resolution.
• Excellent negotiation skills; written/oral communication skills.
• Ability to work under minimal supervision and independently.
• Must be able to work in a timeline-driven environment.
PHYSICAL REQUIREMENTS
• Light lifting
External Responsibilities Plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), IDE, PMA(S), Design Dossiers, Device License Applications, Shonins, and internal “Letters to File”. Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings. Submit U.S. and international regulatory applications including 510(k)'s, IDE's, PMA's, Design Dossier's, Shonins, and Device License Applications.

We are currently seeking multiple individuals for Regulatory Affairs opportunities throughout Medtronic. Qualified candidates with all levels of experience are encouraged to submit an application in consideration for this or similar opportunities. This opportunity is based in Santa Rosa, California. Other opportunities may also exist at our locations in Minneapolis, Minnesota; Northridge, California; Redmond, Washington; Denver (Louisville), Colorado; Ft. Worth, Texas; Memphis, Tennessee; Danvers, Massachusetts; and Jacksonville, Florida.

With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.

TO APPLY: Please submit your resume at www.medtronic.com/employment. Review Regulatory Affairs openings or enter Requisition # 47935 and select "Add to Cart" or "Apply to this Job" to route your resume directly to the hiring department. No agencies or phone calls, please.

Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.