Regulatory Affairs Manager

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Fort Worth, United States Ferris Mfg. Corp. Full time

Ferris Mfg. Corp., a successful and long-established Medical Device Manufacturer, is seeking a responsible, self-motivated, hard-working, and detail-oriented Regulatory Affairs Manager.   This position will perform a variety of administrative duties and responsibilities supporting the entire organization in the production of PolyMem products.  


Responsibilities:

Assure that products comply with national and international laws and regulatory standards. Serve, support, and advise internal departments. Serve customer needs and expectations as required by Ferris’ policy and procedures.

This position will support and advise Manufacturing, Product Development, Marketing and Sales Departments. The RA Manager will assist in Documentation necessary by editing and/or drafting of procedures, work instructions, specifications, records and submissions. Position will be involved in planning for projects, priorities, resources.

Position will support international partners with documentation for registration of products. Participate in Risk Management activities. Will conduct Post Market Surveillance plans/reports and Clinical Evaluation plans/reports in cooperation with Ferris Clinical Support department. PMCF and PSUR plans and reports accordingly. Will be intimately involved in internal audits, external agencies audits and customer audits. RA Manager will maintain compliance with US and International Agencies requirements by monitoring the applicable laws, regulations, standards, marketplace, and culture for effects on Ferris’ manufacturing process, product design and its quality system. Position will participate in activities with regulators, agencies, and auditors such as FDA, AR, and NB. Position will ensure proper regulatory reporting. Position will work with consultants as applicable to accomplish registration submissions.

 

Supervisory Responsibilities:

Position will manage, coordinate, and evaluate RA activities. It will work with and guide others in accordance with Ferris’ policies and procedures. Maintain Ferris compliance with all applicable federal and state laws. Position will cooperate with top management and department supervisors to promote training, implementation, and enforcement of department procedures.


Qualifications:

  • Bachelor of Science degree in some field of Science or Engineering at a minimum, MS or MBA is desirable.
  • 5+ years of experience in quality and/or regulatory management in the medical device industry is desirable.
  • Adept in the use of MS Office Suite
  • Outstanding verbal and written communication skills.
  • Certificates, training and memberships that illustrate the candidate’s experience and expertise.

 

Company Information

Ferris has been producing and distributing the innovative PolyMem wound-care products worldwide for 32 years. Ferris has received numerous awards including the KPMG Peat Marwick High-Tech Entrepreneur Award and Diagnostic Industry’s Medical Design Excellence Awards.

 

Ferris Mfg. Corp. established in 1977 is dedicated to the development and manufacturing of innovative wound-care products for the world professional health care market. Ferris is committed to providing innovative and superior quality products and services to our customers. This position onsite located in our headquarters and manufacturing facilities in Fort Worth, TX. 

 

Ferris offers a variety of healthcare choices including traditional PPO as well as an HSA Medical plan to which company contributions are made each pay period into your Health Savings Account. We also provide a 401K plan with employer matching. Ferris is an equal opportunity employer.

 

 

 

 

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