Posted in General Business 30+ days ago.
Type: Full-Time
Location: Mount Prospect, Illinois
The Regulatory Affairs (RA) Manager is responsible for managing the ongoing development, implementation, and maintenance of a comprehensive Regulatory Affairs system in accordance with medical device domestic and international regulatory requirements. The RA Manager will ensure the implementation of effective processes, policies and procedures that comply with regulatory requirements including UDI and GUDID, Product/Site Registrations, cybersecurity, Software as a Medical Device -SaMD, CE Markings, Label Review/Approval, Adverse Events, Field Actions (i.e., recalls), Declaration of Conformity, product submissions, Buy American Act (BAA) and Certificate of Free Sale. The RA Manager will be an active participant in Regulatory Affairs industry meetings and have an ongoing understanding of global regulatory affairs/compliance intelligence to consistently stay ahead of forthcoming standards and requirements that impact Rauland products and processes. The RA Manager will also support key improvement and product development processes including Management Reviews, Risk Assessments, Internal Audits and Product Life Cycle (Product Design Engineering) initiatives. Support external assessments conducted by consultants, UL, FDA and ISO-13485:2016 Registrar. The Regulatory Affairs Manager has proven leadership skills in working collaboratively across multiple functions and has an in-depth knowledge of multiple areas of Regulatory Affairs/Compliance to proactively drive continuous improvement initiatives, implement value-added performance metrics and work independently with minimal guidance from management. Serves as a technical reference and subject matter expert for colleagues with less experience. This position will provide leadership for improvement projects and will have the ability to solve problems affecting regulatory affairs and compliance.
Major Responsibilities:
Salary Minimum: Market
Salary Maximum: Market
Incentive: No
Disclaimer: Where a specific pay range is noted, it is a good faith estimate at the time of this posting. The actual salary offered will be based on experience, skills, qualifications, market / business considerations, and geographic location.
AMETEK, Inc. is a leading global provider of industrial technology solutions serving a diverse set of attractive niche markets with annual sales over $7.0 billion.
AMETEK is committed to making a safer, sustainable, and more productive world a reality. We use differentiated technology solutions to solve our customers' most complex challenges. We employ 21,000 colleagues, in 35 countries, that are grounded by our core values: Ethics and Integrity, Respect for the Individual, Inclusion, Teamwork, and Social Responsibility. AMETEK (NYSE:AME) is a component of the S&P 500. Visit www.ametek.com for more information.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1 (866) 263-8359.
Nearest Major Market: Chicago
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