Apex Systems is looking for a Regulatory Manager for our medical device manufacturing client in the Mansfield, MA area! PMA experience is required!
For immediate consideration, please send a copy of your most updated resume to Jalen at firstname.lastname@example.org.
The Regulatory Manger is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.
• Deliver innovative regulatory strategies and high-quality submissions that produce timely and predictable worldwide regulatory approvals
• Lead the Regulatory Affairs function for the Patient Recovery business through active participation in functional leadership and decision teams
• Direct a team of Regulatory Affairs Managers and Specialists in the management of new product development/ modification projects to establish and integrate regulatory submissions strategy into project activities
• Coach RA team in the preparation of submissions (i.e. 510k, CE Marking applications, technical documentation, global product registrations, STED, etc.) to obtain global regulatory approvals and maintain existing regulatory approvals through letter to file, renewals, change notifications, etc.
• Determine applicable registration requirements for medical devices in all countries in which products are to be registered
• Interpret and/or evaluate proposed registration requirements for medical devices and advise impact of such regulations on the company
• Coordinate complex logistical details including team resourcing and project timeline planning; liaise with functional group representatives
• Manage and/or oversee communication and submission processes of global registrations including general correspondence, reports, and amendments
• Coordinates submission issues interdepartmentally to ensure compliance and quick and complete resolution
• Support the client's domestic and international manufacturing facilities with foreign government and regulatory body inspections
• Coordinate international registration and appropriate export application forms for Patient Recovery products intended for foreign exportation
• Review device labeling and advertising materials for compliance with regulations
• Maintain proficiency on global regulatory requirements; develop and maintain rapport with regulatory reviewers and project team members
• Plans and implements regulatory policies, procedures, systems, practices, and strategy as required
• Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies
• Travel is required up to 15%
• Bachelors and Advanced degree in scientific field
• 3-5 years' experience in global regulatory affairs in medical devices
• Prior supervisory experience
• QMS experience a plus
• Effective management and team leadership skills
• Effective team building skills
• Ability to create cross-functional partnerships
• Effective negotiation skills
• Ability to work collaboratively in a team environment
• Effective oral and written communication skills
• Ability to manage critical decision-making
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at email@example.com or 844-463-6178.
Posting ID: 552620394Posted: 2020-05-13