Regulatory Affairs Manager

Keystone Industries; Gibbstown (NJ); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Flexible Spending Accounts (FSA)

401(k) Retirement Plan

Fitness Benefits

Paid Time Off & Holidays

Employee Assistance Program (EAP)

Career Development Opportunities

Job summary

A leading manufacturer in Gibbstown, NJ is seeking a Regulatory Affairs Manager to lead the team and ensure compliance with regulatory requirements. The ideal candidate has 5-7 years of experience in regulatory affairs and excellent leadership skills. This role includes overseeing product registrations and managing regulatory compliance across multiple countries. Competitive salary range is $100,000 - $140,000 annually, with benefits including a flexible schedule and career development opportunities.

Qualifications

• Minimum 5 - 7 years’ directly related experience in regulatory affairs.
• Demonstrated knowledge of both domestic and international regulations for regulated products.
• Well organized, articulate, and a team player.

Responsibilities

• Lead and manage the Regulatory Affairs team.
• Oversee the implementation of risk management processes.
• Conduct Internal Auditing and assess compliance.

Skills

Regulatory compliance

Interpersonal skills

Problem solving

Technical writing

Leadership

Education

Bachelor’s degree in chemistry or science-related field

Tools

Microsoft D365

Job description

Join to apply for the Regulatory Affairs Manager role at Keystone Industries

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.

• 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, with preferably 2+ years leadership/people management.
• Location: Gibbstown, NJ (08027)
• Salary Range: $100,000 - 140,000 annually, based on experience and qualifications.

Essential Functions:

• Lead and manage the Regulatory Affairs team, providing guidance, training, mentorship, and support. Set performance goals, conduct regular performance evaluations, and foster a positive and collaborative team environment.
• 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
• 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.
• Attend seminars or educational courses and perform research as needed to provide guidance and meet job responsibilities.
• Perform additional duties/tasks as needed or requested by management.

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.
• 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.
• Training experience.
• RAC, or equivalent certificate from a university
• Ability to navigate highly ambiguous situations.

Education/Certifications:

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

Benefits and Perks:

• Weekly Pay
• Flexible Spending Accounts (FSA) - Medical & Dependent Care or Health Savings Account (HSA) Options
• Company-Paid Life Insurance + Additional Voluntary Options
• 401(k) Retirement Plan with 3% Employer Contribution (after 1 year)
• Fitness Benefits - Onsite Gym (Headquarters) or Membership Reimbursement (other sites)
• Paid Time Off & Holidays to support work-life balance
• Employee Assistance Program (EAP) for confidential support
• Financial Wellness Resources
• Employee Discounts & Perks (Eagles games, concert tickets, etc.)
• Company Social Events & Team Activities
• Career Development Opportunities & Internal Growth

Equal Opportunity Employer