Bose Framingham , MA 01702
Job Description: Medical Device Regulatory Manager:
Develops global Regulatory strategies and updates based on regulatory and business changes. Establish effective relationships with FDA regarding regulatory inquiries and submittals. Prepare 510(k) and CE Technical Files to be used to gain regulatory clearance.
Responsible to ensure documentation, reports, tests, and results meet the requirements of Regulatory Filings. Provide regulatory advice and guidance on device clinical trials. Provide input on standard operating procedures and product specifications in conjunction with R&D and Operations.
Represent Regulatory Affairs in Design Control activities to ensure compliance to procedures, regulations, and standards. Provide guidance for design and development planning, risk management, and design verification and validation. Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others.
Act as the Regulatory representative on Core Team for all RA Compliance initiatives as well as governing committees on strategic initiatives. Represents as required the regulatory function in the evaluation of new product opportunities internally and externally. Manages a budget for resource needs for all initiatives.
Leads or plays a key role on internal Company governance committees Demonstrated track record for successful interactions with FDA and other global health authorities related to CMC submissions. Relationship management and constructive partnering with international Health Authorities Experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with international regulatory authorities is also required. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/BA Degree in a Scientific Discipline or combination of education and relevant work experience. 15+ years medical device regulatory experience, with international experience strongly preferred. Proven ability to liaise with Regulatory Agencies, having served as lead in Agency Interactions and product development meetings, international experience preferred. Understanding of scientific principles and regulatory requirements relevant to global medical device development and post-market support.
Proven ability to provide strategic regulatory guidance to development and commercial teams. Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. Demonstrates leadership, problem-solving ability, flexibility and teamwork Exercises good judgement in elevating and communicating actual or potential issues to management.
Excellent written and oral communication skills required. Active participation in Agency/Industry groups/forums expected. Knowledge of FDA Quality System Regulation (21 CFR 820) and Medical Device Reporting Regulations (21 CFR 803, 806) and ISO 13485.
Bose is an equal opportunity employer that is committed to inclusion and diversity. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other legally protected characteristics. For additional information, please review: (1) the EEO is the Law Poster (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf); and (2) its Supplements (http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm). Please note, the company's pay transparency is available at http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf.
Bose is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the application or employment process, please send an e-mail to Wellbeing@bose.com and let us know the nature of your request and your contact information.