“Join us in building on over 70 years of innovation and manufacturing expertise to keep making history.”
Are you a Regulatory Affairs professional looking for a new challenge and an exciting opportunity to advance your knowledge, skills and career in a great working environment? Would you like to have a job that rewards performance and offers competitive compensation and benefits?
We are looking for a hardworking and enthusiastic Sr. Manager, Regulatory Affairs to join our Corporate Quality dream team and help us drive Regulatory Excellence throughout the company.
The Sr. Manager, Regulatory Affairs is a key position within the Corporate Quality team and accountable for all aspects of Regulatory Affairs within Comar. This role will supervise Corporate Regulatory resources and external regulatory consulting/advisory services, serving as the Subject Matter Expert (SME) across various regulations, standards, and guidelines applicable to Comar businesses and compliance. The Manager, Regulatory Affairs will own regulatory activities to support the day-to-day business, new product development projects as well as ongoing product regulatory maintenance to support total product lifecycle requirements. This role will also be responsible for providing hands on support for the coordination, compilation, and submission of various regulatory documentation; and lead strategies for regulatory compliance, drive alignment with internal and external stakeholders, and develop and implement compliance plans.
THE ROLE
Regulatory Strategy:
Monitor the applicable regulations, standards, emerging trends, and industry best practices and report such changes promptly. Guide the organization to remain in state of compliance.
Work closely with the commercial team to establish regulatory strategy for newer global markets.
Compliance and Quality Management System (QMS):
Partner with the corporate Quality Systems and Compliance staff to ensure the Quality Management System drives compliance with applicable regulations and standards. Evaluate effectiveness of QMS and makes recommendations for improvements.
Provide expert support during internal and external audits, periodic internal reviews, or investigations. Ensure that compliance procedures are followed.
Lead regulatory audits and support Quality audits conducted by notified personnel.
Regulatory Support:
Partner with appropriate regulatory and cross-functional teams to create and maintain various regulatory documentation such as Medical Device Directive (MDD) / Medical Device Regulation (MDR) Technical files, Design History Files, Device Master Records, Regulatory Data Sheets, USP Test Results and Drug Master Files (DMF) etc. in accordance with the regulatory standards.
Proactively work with procurement and Comar vendors to obtain and manage regulatory documentation including product and material compliance data.
Respond to customers’ regulatory requests expeditiously.
Lead post market surveillance activities and appropriate actions in compliance with the regulations.
Primary contact for registered personnel, regulatory authorities, and customers for their regulatory related inquiries. Support customers’ regulatory submission needs.
Make recommendations and provides guidance to marketing, product development, engineering, and technical writers on various regulatory related topics.
Process Ownership and Process Improvements:
Own Regulatory Affairs processes, procedures, and systems. Utilizes Six Sigma/Lean methodologies and drive metrics-based process improvements.
Lead implementation of the European Union Medical Device Regulation (EUMDR) roadmap and achieve successful EUMDR certification.
Effectively communicate and ensure that Regulatory Affairs requirements are fully understood, implemented and/or mitigated in new product, marketing, and other business processes.
Establish a system to collect, track, analyze, and report on a product's environmental compliance or material content regulations.
Create and maintain a usable digital portal of all Comar submissions.
Resources/ People Management:
Manage various regulatory consultants and service providers to maintain annual licenses, registrations, listings in applicable countries/regions.
Provide leadership, coaching and guidance to the staff to drive engagement, collaboration, and sharing of best practices within their team and with other functions. Carry out managerial and administrative responsibilities in accordance with the organization’s policies and applicable laws.
WE ARE LOOKING FOR:
Bachelor’s degree in a scientific or related discipline and 8 years of experience in an FDA regulated food or drug industry OR equivalent combination of education and experience.
ASQ CQM/OE or CQA Certification.
5 years of hands-on experience in regulatory submissions including developing / implementing regulatory strategies for medical device, in vitro diagnostic device and / or pharmaceutical industry.
4 years of experience managing a team of salaried employees.
Prior experience with medical device regulations and Quality Standards in the US and international markets such as Canada, Europe, UK, Switzerland, Latin America, China, Japan etc.
Preferred:
Understanding of plastics manufacturing processes and technology platforms, commonly used especially in medical devices or in pharmaceutical packaging.
Knowledge of 510(k), IDE, PMA Technical File preparation, review, and submission processes.
Regulatory Affairs Certification (RAC).
Safe Quality Food (SQF) Certification.
DO YOU HAVE…?
Thorough understanding of 21 CFR Part 820 Quality Systems, current revision of ISO 13485, ISO 9001 and applicable FDA & EU medical device regulations.
Thorough understanding of global food safety regulations, standards, and best practices.
Inquisitive, self-motivated, excellent leadership qualities with strong mentoring and coaching skills.
Ability to interact with individuals at all levels of the organization, strong written and oral communication skills, and excellent organizational skills with attention to detail.
Ability to prioritize multiple tasks and demands and to create sense of urgency for the fast-paced manufacturing environment.
Experience with Business Process Improvements and understanding of principles and practices of Project Management.
