Senior Director, Regulatory Affairs

Are you a seasoned Regulatory Affairs professional with a passion for ensuring compliance and driving regulatory strategy in the medical device industry? We're are on the look out for a dynamic Regulatory Affairs Director to lead regulatory initiatives for a one-of-a kind start-up in the Medical Device space. As a key member of the team, you'll play a...

Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle. This role is...

Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position Regulatory Affairs, Specialist, Regulatory, Diagnostic, Cardiac, International

Recruiter: Spencer Gregory Hale   Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC   Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.   This...

Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle. This role is...

Responsibilities:Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reportsExperienced in authoring of assessment reports and Part2/ Expert reports for DossiersExperience in reviewing of quality documents such as Reformulation studies, process validations, particle size method...

Support and prepare documentation for regulatory submissions and registrations (FDA and EU regulatory entities) IDE, PMA, 510 (k), Design Dossiers, Technical Files. Maintain regulatory Technical Files Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements...

Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in reviewing of quality documents such as Reformulation studies, process validations, particle size method...

About the role:At Boston Scientific, you'll discover a place where you can find meaningful purpose, improving lives through your life's work. The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This individual will report into the Manager responsible...

Job DescriptionJob DescriptionAegis Worldwide is seeking an experienced Quality Manager to join a contract manufacturer near Lake Forest, IL. Ideally, this individual comes from the Personal Care Industry or a similar GMP environment (Food, Beverage, Chemical, Pharmaceutical). This person will be on track to grow into a Director role in the next couple of...

Job Description Job Description Aegis Worldwide is seeking an experienced Quality Manager to join a contract manufacturer near Lake Forest, IL. Ideally, this individual comes from the Personal Care Industry or a similar GMP environment (Food, Beverage, Chemical, Pharmaceutical). This person will be on track to grow into a Director role in the next couple of...

Job Description You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.AbbVie U.S. Immunology is seeking a Marketing Director to lead the portfolio strategy for our Immunology Account Executives.  This individual will put the IAE team in the best position to win by driving strategic...

Recruiter: Spencer Gregory Hale Regulatory Specialist II, Electrophysiology Pulsed Field Ablation, Regulatory Affairs At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and...

Principal Regulatory Affairs About the role: At Boston Scientific, you'll discover a place where you can find meaningful purpose, improving lives through your life's work. The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This individual will report...

Company Description Do you have HEART? We are looking for individuals who can embrace our mission to purposely brighten and enrich the lives of those we serve with HEART; Hospitality, Excellence, Appreciation, Respect & Teamwork. This individual is responsible for fulfilling leasing and move in goals. They are also expected to maintain a positive image of...

Overview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what's right for the resident. For me, that's a big breath of fresh air."- Sunrise Leader At Sunrise, our Activities & Volunteer Coordinator is responsible for leading the day to day...

Overview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what's right for the resident. For me, that's a big breath of fresh air."- Sunrise Leader  At Sunrise, our Activities & Volunteer Coordinator is responsible for leading the day to day...

Overview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what’s right for the resident. For me, that’s a big breath of fresh air."- Sunrise Leader  At Sunrise, our Activities & Volunteer Coordinator is responsible for leading the day to day...

Overview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what’s right for the resident. For me, that’s a big breath of fresh air."- Sunrise Leader  At Sunrise, our Activities & Volunteer Coordinator is responsible for leading the day to day...

Recruiter: Lukas Daniel Richardson About the role: At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key...