Regulatory Specialist

Merz Pharmaceuticals USA Mesa , AZ 85205

Posted 2 months ago

Position leads the preparation of regulatory submissions based on specific project timelines and requests to the support the business with minimal supervision. Position provides global regulatory inputs to new product development projects and ensuring that the design outputs meet product registration needs leading to successful commercialization opportunities.

Essential Duties and Responsibilities:

Regulatory Submissions:

  • Prepare and submit 510k premarket notification applications for submission to FDA

  • Prepare and submit reports and documents to support international regulatory submissions

Clinical Support:

  • Develop and submit IDE requests, develop and submit IDE reports as required

  • Work with clinical affairs to prepare clinical study reports

Sustaining RA Support:

  • Maintenance of establishment registrations and listings

  • Provide RA input to Operations functions for sustaining project activity

  • Provide RA input to change control and develop change impact assessment documents to gather information and document the required RA maintenance needed based on the proposed product change

  • Responsible for maintenance of product technical files and maintaining CE Marking

New Product Development:

  • Provide RA input to R&D functions for new product development project activity

  • Responsible for RA design inputs that lead to compliance with European directives and other country requirements (CMDCAS, etc.) and regulations

Promotional Material Review:

  • Provide support to currently marketed products, e.g., review labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval

  • Assist in review of labeling changes, advertising and promotional activities

Role related Qualifications/

Skills:
  • BS / BA in degree in life sciences or physical sciences - required

  • 3 years of experience in US and international regulatory approval process in medical devices or equivalent level of regulatory experience - required

  • Previous experience with regulatory submissions including IDE and 510(k) submissions for Class II medical devices - required

  • Experience with international regulatory and notified body submissions - required

  • Previous experience working with aesthetic medical devices - preferred

Knowledge, Skills and Abilities:

  • Good working knowledge of FDA labeling regulations, Quality System Regulations, Medical Device Directive and Canadian medical device regulations - required

  • Good communication skills - preferred

Merz North America is a specialty healthcare company headquartered in Raleigh, North Carolina and dedicated to the development and marketing of innovative quality products for physicians and patients across the United States and Canada. Merz products are distributed through two divisions, Aesthetics and Neurosciences, and are developed with the goal of improving patients' health and quality of life by delivering therapies that bring about real progress. Our future is promising, and we are committed to advancing new therapeutic options and improving patients' lives.

Why choose Merz?

  • Private company with a proud history.

  • Entrepreneurial spirit and culture.

  • Ability to be creative and innovative.

  • We foster a collaborative work environment.

  • Flexibility to design your experience.

  • Work in a fast paced industry.

  • Have fun!

Merz Vision and Values

Our vision is to become the most admired, trusted and innovative company in Aesthetics and Neurotoxins.

Our core values are the principles that unite and define the Merz way of working in every part of the world.

PERSIST IN INNOVATION

COMMIT TO CUSTOMERS AND COLLEAGUES

DELIVER TRUSTED RESULTS

Merz Operating Norms

ASSUME POSITIVE INTENT

OBLIGATION TO ENGAGE

COLLABORATE CROSS FUNCTIONALLY

MERZ IS ON THE MOVE!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the companies legal duty to furnish information.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
MidLevel Accommodation Services Specialist

Boeing

Posted 3 days ago

VIEW JOBS 11/16/2018 12:00:00 AM 2019-02-14T00:00 The Boeing Company is recruiting for an Accommodation Services Specialist (Mid-Career) in Mesa, AZ. This position will be part of Boeing Health Services and will be part of a team of Accommodation Services Specialists that will provide creative and effective services and solutions for employees with a variety of health issues in support of approximately 150,000 Boeing employees. POSITION RESPONSIBILITIES * Administer, coordinate and document the activities required for employees and applicants requesting reasonable accommodation due to a medical need. * Facilitate the interactive process with managers and employees to address individual needs, workplace accommodations, and compliance requirements. * Engage appropriate resources and provide assistance in the acquisition, and implementation of accommodation solutions. * Consult, coordinate, and partner with Health Services, HR, Safety, Legal, Payroll, Benefits, team members and other departments/systems as appropriate. * Administer and document the reassignment process for employees who are unable to perform essential job functions. * Oversee and provide case management for complex accommodation cases and provide risk-mitigating solutions, advice, and guidance in compliance with company policies, processes, state and federal regulations. * Maintain system records to ensure accurate and timely information/documentation. * Serve as internal consultant on complex matters related to all aspects of the reasonable accommodation process. * Support and participate in the Enterprise Reasonable Accommodation Focal network meetings and provide guidance to Enterprise Reasonable Accommodation Focal. * Respond to inquiries via the Accommodation Services customer service line. * Provide consultative services, education, training and technical assistance to employees, management, Human Resource Generalists, Boeing Health Services, Reasonable Accommodation Focal and other resources regarding company policies, processes, and state and federal regulations pertaining to the area of reasonable accommodation. * Support Global Talent, Diversity & Inclusion organization in the development of training, tools, and procedures, and evaluation of the health of the reasonable accommodation process. * Maintain and protect medical confidentiality. This position is located in Mesa, AZ and does not offer relocation assistance. Applicants must reside in area or be willing to relocate at their own expense. Boeing is the world's largest aerospace company and leading manufacturer of commercial airplanes and defense, space and security systems. We are engineers and technicians. Skilled scientists and thinkers. Bold innovators and dreamers. Join us, and you can build something better for yourself, for our customers and for the world. Division Human Resources & Admin Relocation Assistance Available No. Relocation assistance is not a negotiable benefit. Qualifications Typical Education / Experience: Bachelor's and typically 6 or more years' related work experience, a Master's degree and typically 4 or more years' related work experience or an equivalent combination of education and experience. Basic Qualifications (Required Skills/Experience): * This position must meet Export Control compliance requirements, therefore a "US Person" as defined by 22 C.F.R. § 120.15 is required. "US Person" includes US Citizen, lawful permanent resident, refugee, or asylee. * Minimum 3 years of experience in conducting reasonable accommodation case management, as required by, and in compliance with, the Americans with Disabilities Act * Current knowledge of federal and state disability laws and regulatory requirements, including the Americans with Disabilities Act and the Family Medical Leave Act * Experience with all phases of the reasonable accommodation process, including initiating, administering, closing, and documenting cases * Experience providing consultation and training on reasonable accommodation and disability issues to employers, managers, Human Resources, and other employee groups Preferred Qualifications (Desired Skills/Experience): * Bachelor's degree or higher * Ability to manage multiple complex assignments and be a liaison between multiple groups and organizations * Ability to keep detailed records and documentation in a timely fashion * Experience training employees and managers on complex issues * Knowledge and experience regarding medical confidentiality and privacy issues * Experience using Microsoft Word, Excel, PowerPoint, and Access to compose and edit documents Experience Level Individual Contributor Job Type Standard Travel No Contingent Upon Program Award No Union No Job Code 7BTTP3 Boeing Mesa AZ

Regulatory Specialist

Merz Pharmaceuticals USA