Qualcomm Manager of Regulatory Affairs in Andover, Massachusetts
Job Id E1959262
Job Title Manager of Regulatory Affairs
Post Date 10/10/2017
Company-Division Qualcomm Life, Inc.
Life at http://www.qualcomm.com/solutions/healthcare
Job Area Engineering - Manufacturing/Quality/Other
Location Massachusetts - Andover
California - San Diego
Job Overview The Manager of Regulatory Affairs will provide regulatory guidance and strategic assessment in support of new product development, product sustaining, and maintenance of business projects.
This position is located in Andover MA, San Diego CA or Minneapolis MN
Lead Regulatory Affairs in the management of new product development and modification projects to establish and integrate regulatory submissions strategy into project activities
Coach team members in the preparation of submissions (e.g. 510(k), CE marking applications, technical documentation, etc.) to obtain domestic filings, European regulatory approvals, and maintain existing regulatory approvals through letter to file, renewals, change notifications, etc.
Responsible for generating and submitting all the regulatory and registration applications to allow the company to market its products domestically and internationally.
Develops and plans strategies to obtain regulatory approvals/clearances to market products.
Determine applicable registration requirements for medical devices in all countries in which products are to be registered
Interacts with and negotiates with regulatory agencies worldwide either directly or through subsidiaries or distributors.
Contribute to team resourcing and project timeline planning
Review device labeling and advertising materials for compliance with regulations and product filings
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
All Qualcomm employees are expected to actively support diversity on their teams, and in the Company.
8+ years' in medical device regulatory affairs role
5+ years experience with software and capital equipment medical devices
5+ years regulatory submissions (510(k), IDE) to FDA and Technical Files/Design Dossiers to Notified Bodies.
5+ years experience in presentations to, and negotiating with FDA (CDRH) personnel and Notified Body Representatives on regulatory submission strategies and product approvals.
Travel Requirement- National/International up to 25%
Effective management and team leadership skills
Ability to create collaborative, cross-functional partnerships
Effective negotiation skills
Effective presentation and communication skills
Critical Thinker/Decision Maker Able to solve problems and make sound decisions
Education Requirements Required: Bachelor's -BS/BA degree in a technical discipline
EEO employer: including race, gender, gender identity, sexual orientation, disability & veterans status.