Regulatory-Affairs-Specialist, Regulatory-Affairs-Manager, Regulatory-Compliance-Specialist Jobs

POSITION SUMMARY:

The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.

PRIMARY RESPONSIBILITIES:

• Understands and interprets U.S. and EU and international medical device and in vitro diagnostic device (IVD) regulatory requirements.

• Provides guidance on requirements to product development teams.

• Develops strategies for submissions to FDA and other regulatory agencies.

• Provides risk assessments and regulatory options.

• Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements. Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S. Interacts and negotiates with U.S. regulatory agencies.

• Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.

• Participates in the development and review of product release documents.

• Reviews clinical protocols to assure collection of appropriate data for regulatory submissions.

• Periodically monitors status of clinical studies and reviews analysis of resultant clinical study data.

• Based on these data and considering the regulatory requirements, recommends appropriate courses of action.

• Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies.

• Provides regulatory opinions on premarket regulatory requirements, export, and labeling requirements.

• This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job.

• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

• Must maintain a current status on Natera training requirements.

QUALIFICATIONS:

• Bachelor's degree or equivalent; degree in biological sciences, chemistry, or related science strongly preferred.

• Minimum 5 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs or equivalent.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards.

• Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.

• Ability to organize work, project management experience desirable.

Originally posted on Himalayas

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our Wound Closure and Healing group. Preference will be given to candidates located within a commutable distance of Raritan, NJ however remote work options will be considered on a case by case basis and if approved by the company.

Purpose: The Senior Regulatory Affairs Specialist (Regulatory Affairs Specialist III) provides regulatory guidance to project teams in strategic planning and related submissions to support Ethicon Wound Closure & Healing (WCH) products. Under minimal supervision, the individual is responsible for developing and executing global regulatory strategies to support new, modified and currently marketed medical devices. This includes the preparation of regulatory documentation for submissions to regulatory health authorities (i.e. European Notified Body, BSI, European MDR, and FDA). He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Specialist III helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures, and systems.

You will be responsible for:

• Ensures compliance with regulatory agency regulations and interpretations.
• Prepares responses to regulatory agencies' questions and other correspondence.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
• Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance.
• Provides regulatory guidance to project teams and responds to product information requests.
• Provide Regulatory Affairs support during internal and external audits and assists in leading the development best practices for Regulatory Affairs.
• Represents Regulatory Affairs on cross-functional project teams.

Functional and Technical Competencies:

• Leverages scientific and technical understanding of regulated products within the scope of responsibility to provide regulatory input to product development and lifecycle management and evaluate regulatory impact on products.
• Contributes to the development and execution of effective, results-oriented regulatory strategies aligned with business objectives, focusing on the priorities that matter most for patients and the business.
• Evaluates available facts, benefits, risks, and Credo considerations to support sound decisions, seeking guidance as appropriate in ambiguous or unclear situations.
• Supports complex projects and delivers with discipline and accountability by establishing clear priorities, using facts to solve problems, and making timely and effective decisions to execute project deliverables.
• Brings relevant external, customer, and regulatory perspectives into the work and collaborates effectively across functions and levels to develop solutions and advance regulatory objectives.
• Identifies opportunities to improve and simplify regulatory ways of working while maintaining appropriate controls and compliance requirements.
• Demonstrates continuous learning and communicates openly, directly, and constructively to support effective decisions, problem-solving, and execution. Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver business results.

Qualifications / Requirements:

• Minimum of a Bachelors Degree from accredited college or university is required, Advanced Degree strongly preferred. Science, biomedical engineering, medical / scientific writing, public health administration field of study desired.
• At least 4+ years of regulatory affairs or related/equivalent experience (2+ with Advanced Degree) is required.
• Experience with healthcare products (Consumer and/or Pharmaceutical and/or Medical Device) industry and regulations is required.
• Knowledge of US and OUS health products regulations is preferred.
• Previous medical device submission experience is preferred.
• Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes.
• Ability to communicate clearly and accurately, both verbally and in writing, to a widely varied audience.
• Ability to work well under deadlines.
• Excellent written and communication skills, fluency in English.
• Good judgement/decision making and problem-solving ability, capable of understanding the impact of decision making.
• Motivated and an enthusiastic self-starter with the ability to work under own initiatives and as a team player.
• The position is preferred to be located in Raritan, NJ or can be remote in the United States for the right candidate with up to 10% travel is required.

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 , internal employees contact AskGS to be directed to your accommodation resource.

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Originally posted on Himalayas