Regulatory Affairs Manager Jobs

Company
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

• Ideal Candidate: The ideal candidate will have 5-7 years of regulatory experience in medical device, pharmaceuticals, and/or cosmetics. Previous leadership experience a must. Experience with FDA 510K Submissions highly desired.
• Schedule: 8:30 am - 5:00 pm, M-F. *This position is ONSITE in an office setting but has hybrid options.
• Title: Regulatory Affairs Manager
• Location: Gibbstown, NJ (08027)

Provides professional regulatory support through independent management of assignments. This includes but is not limited to maintenance and submission of regulatory filings, sharing and demonstrating current and accurate knowledge of products and regulatory requirements affecting products, interacting with others inside and outside the Company, and working with and assisting other Regulatory Affairs staff. Supervises day-to-day activities and operations of Regulatory Affairs staff.
Essential Functions

• 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.
• 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 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.
• Provide guidance and assign projects/tasks.
• Product Registrations
• Assesses the impact of regulatory changes on the company's products and processes and ensures compliance with these requirements.
• Interacts with internal and external customers, regulatory authorities, both domestic and international, regarding product submissions, change notifications, and where applicable inspections.
• Keeps abreast with the latest relevant regulations, standards, and guidelines and communicates regulatory changes to appropriate departments.
• Acts as a Person Responsible for Regulatory Compliance in accordance with applicable EU Regulations.
• Conducts Internal Auditing
• Product Development/Commercialization
• Regulatory Compliance
• Develops and implements regulatory strategies to facilitate the successful introduction and commercialization of regulated products.
• Supervision of Regulatory Staff
• 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.
• Collaborate with QA to ensure the quality management system (QMS) complies with relevant regulations and standards.
• Provides overall regulatory support and guidance to Regulatory Staff and external customers.
• Advise project teams on premarket regulatory requirements.
• Coordinates biocompatibility and/or safety evaluations as needed.

Qualifications

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

Desired Skills

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

Education/Certifications

• Bachelor’s Degree in chemistry or science-related field

Safety

• Complies with all safety regulations; always maintains a safe work environment.
• Adheres to always wearing the proper PPE/Safety equipment.
• Understands and complies with all written safety, health, and environmental procedures.
• Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets.
• Participates in required Health, Safety and Environmental initiatives and programs.
• Attends all required scheduled Health, Safety and Environmental training sessions.

Benefits/Perks

• Employee Assistance Program (EAP)
• Accident and Critical Illness Insurance
• Medical, RX, Dental, and Vision Plans
• Tuition Assistance Program
• Employee Referral Bonus Program
• Voluntary Term Life/AD&D Insurance, Short-Term and Long-Term Disability
• Pet Insurance
• Company social events throughout the year including tickets to sports events and concerts
• Weekly Pay
• Flexible Spending Account (FSA) – Medical, Dependent Care, & Commuter
• 401K Plan with Employer Contribution
• Paid Holidays
• On-site free Fitness Center with personal trainer (Gibbstown)
• Company-sponsored Life Insurance
• Free Lunch Daily (Gibbstown)