Senior Regulatory Affairs Specialist, Endoscopy

Senior Regulatory Affairs Specialist - Endoscopy
The Senior Regulatory Affairs Specialist, Endoscopy will prepare submissions to obtain and maintain global regulatory approvals for clinical research and commercial distribution of endoscopy products.  Provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.  Act as a company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.  Develop and implement regulatory strategies for new and modified products.  Provide regulatory guidance and direction as a core member on manufacturing and development teams, throughout the product development cycle, and identify/coordinate cross functional deliverables for submissions.  Review and approve device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.  Review and approve product and manufacturing changes for compliance with applicable regulations.  Develop and implement departmental and divisional policies and procedures.  Support highly technical or major business segment product lines, special projects or strategic initiatives.  A bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline is required, professional certification(s) preferred.  5 to 8 years regulatory affairs medical industry experience is required. Device experience required. International experience is a plus. Demonstrated success in management of regulatory submissions activities.  Thorough understanding of global regulations.  Strong technical knowledge of medical products.  Strong technical understanding of relevant procedures, practices, and associated medical terminology.  Strong knowledge of clinical trial strategy and study design and sponsor reporting requirements.  Thorough knowledge of product development process and design control.  Excellent research and analytical skills.  Ability to manage multiple projects.  Excellent written and oral communication, technical writing and editing skills.  Strong leadership, interpersonal and influencing skills.  Proficiency with Microsoft Office.

Please refer to job code SD6770 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Berlin, MA
County:	Worcester County
ZIP Code:	01503
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856