Regulatory Affairs Manager

Company Overview:

We are passionate about our employees.  We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development.  Come join the Keystone team so we can build your career together!

In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. 

Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities.

Position Details:

• Title: Regulatory Affairs Manager 
• Schedule: 8:30 am - 5:00 pm, M-F, with some flexibility. *This position is ONSITE in an office setting, potential for 1 day remote* 
• Ideal Candidates: Ideal candidates will have 5-7 years of experience in Regulatory Affairs, with preferably 2+ years leadership/people management.
• Location: Gibbstown, NJ (08027)

Essential Functions:

• Product Registrations
  • Interacts with internal and external customers, regulatory authorities, both domestic and international, regarding product submissions, change notifications, and where applicable inspections.
  • Coordinates and manages the preparation and submission of regulatory document required for product registration in USA, EU, Canada, Australia, Brazil, Japan and other countries as requested.
  • Maintains annual facility registrations and product listings for drugs, medical devices, and cosmetics where applicable.
  • Works closely with cross-functional teams to gather and compile the necessary data for technical files and product information files.
• Regulatory Compliance
  • Acts as a Person Responsible for Regulatory Compliance in accordance with applicable EU Regulations.
  • Keeps abreast with the latest relevant regulations, standards, and guidelines and communicates regulatory changes to appropriate departments.
  • Assesses the impact of regulatory changes on the company's products and processes and ensures compliance with these requirements.
  • Collaborate with QA to ensure the quality management system (QMS) complies with relevant regulations and standards.
  • Appropriately checks the conformity of the device prior to release and where applicable, issues Declaration of Conformities.
  • Oversees activities related to post-market surveillance and vigilance reporting.
  • Conducts Internal Auditing
• Product Development/Commercialization
  • Develops and implements regulatory strategies to facilitate the successful introduction and commercialization of regulated products.
  • Advise project teams on premarket regulatory requirements.
  • Advise on export and labeling requirements.
  • Oversees the implementation of risk management processes. Work with cross-functional teams to identify and address potential risks associated with regulated products.
  • Coordinates biocompatibility and/or safety evaluations as needed.
• Supervision of Regulatory Staff
  • Provides overall regulatory support and guidance to Regulatory Staff and external customers.
  • Provide guidance and assign projects/tasks.

Qualifications:

• Minimum 5 – 7 years’ directly related experience in regulatory affairs.
• Previous experience in leadership role with ability to lead, motivate, and develop a team.
• Strong interpersonal skills – ability to interact and communicate/collaborate at all levels internally and externally.
• Demonstrated knowledge of both domestic and international regulations for regulated products, such as medical devices, pharmaceuticals, and/or cosmetics.
• Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and Quality Management Systems (QMS).
• Familiarity with international market labeling and registrations.
• Strong problem solving and multi-tasking skills.
• Strong computer skills
• Excellent writing skills – position requires technical writing/documentation.
• Well organized, articulate, a self-starter, responsive and a team player.

Desired Skills:

• Experience with the FDA 510K Submissions and EU MDR
• Microsoft D365 software experience.
• Audit experience
• Training experience
• RAC, or equivalent certificate from a university
• Ability to navigate highly ambiguous situations.

Education/Certifications:

• B