Regulatory Affairs Manager
Plymouth - Medtronic
Work with direct reports to develop successful global regulatory strategies to ensure timely device approvals.
Provide direction and leadership to Regulatory Affairs Specialists in the development and implementation of global regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. Provide management support to submissions, regulatory activities, clerical staff, and supervise the preparation of deliverables to introduce new/ changed products to global markets.
Lead negotiations with regulatory agencies.
Foster collaboration with geographies and global marketing to develop effective global launch plans.
Manage complex issues and execute to plan
Provide management and leadership to the Regulatory Affairs organization in such areas as personnel, objectives, projects and responsibilities.
Contribute to the development and implementation of business unit strategic and operating plan
Provide strategic work direction, training and regulatory advice to direct reports and other members of the regulatory department. Interview and hire staff as necessary. Review personnel decisions to ensure harmony with overall department goals.
Review submissions of regulatory staff and coach to ensure continuing development of regulatory skills.
Keep Senior Management informed of regulatory status of products and significant regulatory issues, and update them about new developments.
Direct submission negotiations with Notified Bodies, FDA, as needed (depending on level of experience of Regulatory Affairs Specialist), including pre-submission identification of requirements and strategy and post-submission negotiations to ensure timely approval.
Maintain proficiency on global regulatory requirements and develop and maintain rapport with Notified Bodies, FDA reviewers, in-country regulatory affairs personnel, group leaders and ancillary personnel.
Conduct annual performance reviews. Assist with setting of objectives and professional development of staff.
Provide continuing regulatory education and dissemination of regulatory information to the development, operations, development, marketing and clinical groups.
Oversee a portion of the department budget; approve spending within defined limits.
Be able to deal with advanced concepts and undefined paths. Develop new solutions based on industry experience and working collaboratively with other functions and businesses. Communicate options and recommend solutions to a wide range of difficult problems.
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
YEARS OF EXPERIENCE
5+ years' project / people management experience, in regulatory/quality system / medical device environment.
1+ year experience interfacing with regulatory agencies
Experience at formulating successful regulatory strategies that meet aggressive preparation and approval timelines, while maintaining the highest level of quality and compliance
Highly motivated and results-oriented leader
Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, All Phases of FDA Device Law/Regulations, Global Regulatory Requirements/Procedures, Project Management, Negotiations, Medtronic Product/Design/ Development Systems
Proficiency in FDA compliance
Excellent written and verbal communication, technical writing, and editing skills.
Demonstrated advanced software skills including Microsoft Word, excel, database (i.e. RAD/Documentum) and Adobe software skills.
Excellent Project-management skills and experience.
Presentation skills for small to mid-sized groups
Ability to be flexible with changing priorities.
Submission-related word processing skills
Ability to travel approximately 20%