Principle Responsibilities and Duties:

This professional provides direct support to Solta operations for their globally distributed products. This role is not a regional regulatory but global regulatory position which under the organization of Solta Medical Inc.  They work closely with site Quality, R&D, Operations, and regional RA peers to support global licensing and registrations, and to ensure the effective execution and management of changes. 

Responsibilities

•    Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product portfolio which been assigned.
•    Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
•    Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE Marking, global product registrations, and clinical evaluations.
•    Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. 
•    Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. 
•    Ensures budgets and schedules meet corporate requirements. 
•    Conducts research and communicates new and revised regulatory requirements to the organization, performs/coordinates impact assessment activities, and supports implementation of changes as required.
•    Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

Qualifications

•    10+ years of experience in medical device industry. 5+ years of experience in Electrical/Active medical device industry. 
•    5+ Working knowledge of appropriate global medical device regulations, requirements, and standards. 
•    2+ years of people management; direct & indirect. 
•    Should have experience of independently authoring complete 510k submissions, Health Canada Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above).
•    Experience in participating in national or international standards activities. 
•    This position requires a minimum of an undergraduate degree, preferably in a science related field.
•    Must have a solid understanding of Change Management /Life Cycle.
•    Management of medical device products along with the impact of changes on US Canada and EU.
•    Possess a self-directed & problem-solving mindset.
•    RAC preferred but not required.
•    Must possess the ability to work highly effectively in cross-functional teams and must thrive in a dynamic, fast-paced environment.
•    Excellent written and communication skills.

The range of starting base pay for this role is $146K-$200K.  Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, , Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.

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