Senior Director, Quality, Regulatory & Clinical Affairs

Senior Director, Quality, Regulatory & Clinical Affairs - Permanent - Greater Boston, MA Area

Proclinical is seeking a Senior Director, Quality, Regulatory & Clinical Affairs for a leading global specialty measurement company with their location in the Greater Boston, MA Area.

Primary Responsibilities:

In this role, you will be responsible to work through multiple levels within the organization and external stakeholders to influence and drive Quality, Regulatory & Clinical Affairs strategy to support business growth and success of the Clinical organization. This role will be part of the Clinical Leadership Team and report directly to the Vice President, Clinical R&D and QRC.

The position will be hybrid in the Greater Boston, MA Area (2 days per week onsite) with up to 25% travel internationally.

Skills & Requirements:

• Minimum of an Advanced degree (PhD, M.S.) in a Life Science, MBA or equivalent
• Proven extensive [+15yrs] regulatory affairs experience with medical devices, IVD experience essential.
• Extensive and proven understanding of FDA and global regulations, including China, Europe (IVDR), India, and Brazil
• Significant [7+ yrs] managerial experience, including across multiple locations.
• Proven experience with the development of global regulatory strategies.
• Experience with Design Assurance management for Class I/II/III medical devices/systems and/or in-vitro diagnostics experience.

The Senior Director, Quality, Regulatory & Clinical Affairs will:

• Lead the Global Design Quality Assurance, Regulatory & Clinical Affairs functions for the Clinical Business Unit, with emphasis on global strategy for in vitro diagnostic clinical business activities.
• Lead regulatory strategy planning and execution for all key clinical programs globally.
• Oversee the process of preparing product submissions and registrations to domestic and international regulatory bodies, managing the process from inception to approval and maintenance.
• Manage and conduct Regulatory Affairs activities including those related to New Product Development, Change Management, Post Market, potential Adverse events.
• Interact with FDA and other global regulatory bodies plus registration authorities as required to ensure timely, effective submissions.
• Establish, develop, and manage relationships with international regulatory agencies and standard bodies, act as the company representative providing input to application of existing regulations and proposed changes.

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.