Regulatory Affairs Specialist II

Key Responsibilities:

Under moderate supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson procedures and guidelines:

• Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies and assists in responding to regulatory authority queries and deficiency letters.

• This includes but is not limited to 510(k), IDE, PMA, HDE, PMA/HDE Annual Reports, Technical Documentation Assessments, Design Examinations, Change Notifications (EU/UK), and other correspondence for new products and changes to existing products.

• Completes assignments for the creation and maintenance of regulatory documents and records related to FDA submissions, Technical Documentation, Design Dossiers, Letters to File, regulatory impact assessment of changes, and other regulatory documents for medical devices, including US Class II and III devices and EU MDR Class III devices.

• Reviews proposed labelling, packaging, and promotional materials to evaluate conformance to applicable global market regulations.

• Completes assigned duties in compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures.

• Collaborates with others

• Attends regular meetings with project teams for product development and product changes, communicating applicable regulatory requirements and activities needed to gain and maintain regulatory approval in various markets.

• Collaborates with other Regulatory team members in preparing and documenting communications (verbal and written) with FDA, EU Notified Bodies, and other external regulatory agencies

• Communicates relevant technical and regulatory information to global partners to obtain local regulatory impact, and to complete required regulatory submissions.

• Provides Regulatory Affairs support for internal and external audits to comply with ISO 13485 and related standards.

Experience and Education

Required: BS with 2+ years of experience, or PhD, MS degree

Preferred: Training in US and/or EU medical device regulations

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.

• Strong written and verbal communication skills, especially for conveying technical, scientific, and medical information in multiple technology formats and to different audiences

• Some knowledge of US and European regulatory processes

• Experienced in working as a member of a team

• Ability to communicate in a constructive manner to encourage new, diverse ideas so decisions can be made in alignment with business objectives and the J&J Credo

• Capability to work in an environment of innovative thinking, informed risk taking, intellectual curiosity, and continual learning of regulatory developments

Additional position requirements

• Preferred: Practical experience in a medical device regulatory environment

• Preferred: Practical experience working within a medical device quality system

• Preferred: Practical experience preparing submissions for Class II and III medical devices in the US and EU

• Language requirement: Proficiency in speaking, reading, and writing in English

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

Works with other departments such as Research and Development (R&D), medical affairs, clinical, Marketing, Supply chain and other functions to achieve business objectives.

Physical working conditions / requirements

This position does not involve conditions that may require special or unique physical abilities

Location & travel requirements

Expected domestic and international travel: 5%–10%

Additional Information

• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.  

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). 

• Employees are eligible for the following time off benefits: 

  • Vacation – up to 120 hours per calendar year  

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year  

  • Holiday pay, including Floating Holidays – up to 13 days per calendar year 

  • Work, Personal and Family Time - up to 40 hours per calendar year  

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Collaboration, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments

The anticipated base pay range for this position is :

$76,000.00 - $121,900.00

Additional Description for Pay Transparency: