Regulatory Affairs Leader Job in Westborough, Massachusetts US

Regulatory Affairs Leader

Job Description Job Number: 1486505 Business GE Healthcare Business Segment: Healthcare Quality About Us: GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare's expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, and biopharmaceutical manufacturing technologies is enabling healthcare professionals around the world to discover new ways to predict, diagnose and treat disease earlier. We call this model of care "Early Health." The goal: to help clinicians detect disease earlier, access more information and intervene earlier with more targeted treatments, so they can help their patients live their lives to the fullest. Re-think, Re-discover, Re-invent, Re-imagine. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people - a highly diverse, top-talent workforce - committed to serving healthcare professionals and their patients in more than 100 countries. GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation. GE Healthcares Life Sciences business is committed to helping researchers understand life at a molecular level so that new approaches to prevent, diagnose, treat and cure diseases can be developed. Posted Position Title: Regulatory Affairs Leader Career Level: Experienced Function Quality Function Segment: Quality Assurance and Regulatory Affairs Location: United States U.S. State, China or Canada Provinces: Massachusetts City: Westborough Postal Code: 01581-1019 Relocation Assistance No Role Summary/Purpose: The Regulatory Affairs Leader provides subject matter expertise in cell therapy with understanding of regulatory requirements for clinical and translational research. Works with a team of regulatory affairs professionals to ensure that GE Healthcare Life Sciences establishes best practice within the assigned area of responsibility, such as regional regulatory submissions reporting, technical standards, collection and dissemination of intelligence, global regulation. Essential Responsibilities - Work closely with regulatory, engineering, marketing, legal and other professionals across the company to develop implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility. - Identify regulatory trends and their implications for GE Healthcare; Develop implement effective regulatory strategies to meet business objectives - Analyze communicate proposed, new or changing requirements devise strategies for their implementation, ensuring business goals are met. - Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility. - Educate, train advice company professionals to ensure compliance with RA requirements. - Audit business units for compliance and consistency and track/address trends observed that could lead to non-compliance or risk to patient/user safety. - Collect, summarize evaluate performance metrics to identify program weaknesses drive improvements in procedures or oversight. - Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility. Qualifications/Requirements: - Bachelors Degree in Life Sciences or related discipline - Regulatory Affairs experience from Biologics, Pharmaceutical or Medical Device industry or government / government relations - Demonstrated knowledge experience conducting scientific, regulatory, legal, or business research - Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner - Ability to work well independently in a team setting across cultures/countries/sites - Has engaged with regulatory bodies to support development of regulatory requirements, such as the FDA - Has worked with RD, manufacturing and/or sales to establish regulatory compliant operational systems and processes Additional Eligibility Qualifications GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics - Experience with medical device regulatory requirements in both the US, Europe (EU), preferred; Asian market experience desirable - Experience with cell therapy products, blood products and / or biological desirable but not mandatory - Bachelors or higher degree in Cell Therapy or Regulatory Affairs, not mandatory - Demonstrated ability to manage independent responsibilities and execute decisions - Preferred experienced in communication with Regulatory Authorities, Facilitation, Project Management and risk analysis - Regulatory Affairs Certification (RAPS), not mandatory - Knowledge of Quality Management Systems (QMS) desirable - Strong problem solving and negotiation skills - Demonstrated understanding of healthcare environment and knowledge of current competitive commercial or political situations and their impact on regulatory strategies