Qualcomm Manager of Regulatory Affairs in Andover, Massachusetts
Job Id N1956416
Job Title Manager of Regulatory Affairs
Post Date 06/20/2017
Company-Division Qualcomm Life, Inc.
Life at http://www.qualcomm.com/solutions/healthcare
Job Area Engineering - Manufacturing/Quality/Other
Location Massachusetts - Andover
Job Overview The Manager of Regulatory Affairs will lead the regulatory department responsible for the support of new product development, product sustaining and maintenance of business projects. Specific activities include but are not limited to:
Lead the Regulatory Affairs department in the management of new product development/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 strategiesEssential Functions:
Coach and mentor professionals
Monitor/strategize/navigate evolving global regulatory landscape
Prepare and execute effective presentations
Interface with all levels of management and regulatory body representatives
Create and maintain regulatory filings (e.g. product submissions)
Review change control documents and ascertain regulatory impact
Recommend strategies based on current local registration requirements and applicable industry standards
Drive process and system improvements
7+ years professional experience in the medical device
4+ years in medical device regulatory affairs
5+ years preparation of regulatory submissions (510(k), IDE) to FDA and Technical Files/Design Dossiers to Notified Bodies.
5+years presenting and negotiating with FDA (CDRH) personnel and Notified Body Representatives on regulatory submission strategies and product approvals.
5+ years non-medical and medical software and hardware products.
Ability to create cross-functional partnerships
Effective management and team leadership skills
Effective negotiation skills
Ability to work collaboratively in a team environment
Effective oral and written communication skills
Ability to manage critical decision-making
Effective problem-solving skills
Strong written and verbal communication skills Strong technical writing skills
Ability to work on project teams including cross-functional collaboration and negotiation.
Ability to solve problems and make sound regulatory decisions
Education Requirements Required: Bachelor's
B.S. or B.A. degree in a technical discipline or equivalent experience.
EEO employer: including race, gender, gender identity, sexual orientation, disability & veterans status.