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Manager-Product Safety & Regulatory Affairs (Remote Based, East Coast)

Location: 

Allendale, NJ, US

Req ID:  1355
Job Type: 

We are a global team of 6000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

 

 

Primary Purpose of this position:

The Product Safety and Regulatory Affairs Manager will be responsible for managing the safety and regulatory affairs for medical devices, including advising the business on medical device quality system regulations. The individual will develop the safety and regulatory strategy for medical devices by interfacing with regulatory bodies, consultants, industry associations and internal team members. This position will prepare and submit domestic and International regulatory applications and filings including 510(k)s and other Technical Files. This position is expected to provide regulatory and safety direction on project teams and interface with government agencies such as FDA, Health Canada and others.

 

Thought leader and strategic assessment in product safety, overseeing risk assessments to highlight a path to achieve business goals.  Cutting edge awareness of risk assessment techniques.  Set strategy for key product defense and advocacy initiatives. Advises and proposes proactive solutions to businesses and customers using emerging trends in toxicology to assess human health evaluation.  Leads Product Safety team in setting policy, choice of risk assessment tools and tactics for evaluation to meet departmental goals, customer needs and business objectives.  Sets vision for improvements in screening methods to support new material selection. Advises leadership team, formulators, designers and engineers, supporting technological breakthroughs and advances leading to competitive advantage. Maintains awareness, educates internal team and business about current and new test methods, including preclinical regulatory and testing requirements. Effectively communicates the significance, relevance and interpretation of key study findings to project teams and management. Evaluates and critiques senior scientist’s reviews and reports in order to problem-solve test failures and unexpected results. Advises design of special toxicology studies to support new product development and regulatory submissions, and weighs business merit. Leads scouting and selection of external subject matter experts.  Develops and evolves safety and risk assessment programs in support of new product development and global regulatory approvals.

 

Essential Functions:

  • Conduct safety risk assessments for all new raw materials and products following FDA/EPA risk models to support global, federal, state and local safety requirements, including California Proposition 65.
  • Review final device and draft rationale for release to market.
  • Select appropriate testing to demonstrate substantial equivalence based on FDA guidance documents.
  • Develop test protocols, field assays and review and interpret data for all regulatory submissions including preparation of all safety clearances and final test reports.
  • Provide input to Quantitative Risk Assessment and FMEA.
  • Support response to inquiries from Consumer Affairs and Retailers.
  • Responsible for obtaining and renewing Medical Device Establishment Licenses in North America. 
  • Prepare, assemble and execute regulatory submissions, such as 510(k) submissions and international regulatory registration/ product licenses in various countries.
  • Prepares regulatory strategies for medical devices products to determine regulatory pathways to market including FDA Letter to File, or rationales for devices.
  • Determine regulatory filing strategies and submission types. Participate in medical device product development teams and develop overall regulatory strategy that delivers on project costs, timeline and FDA approval. Ensure that project work proceeds according to agreed deadlines and maintain status records.
  • Responsible for performing all duties in compliance with FDA's Quality Systems Regulations, GMP's, ISO13485; and other international regulatory requirements. The manager will also compile and/or review all regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
  • Compile regulatory and safety documentation for inspection readiness and participate in inspections as a subject matter expert.
  • Participate in root cause analysis, corrective and preventive actions for product and process issues, including internal and external audits, as necessary.
  • Determine governmental regulations affecting Company processes and assure the processes are complete and accurate to ensure company compliance.
  • Act as liaison for Company with regulatory agencies, as well as with other internal functional departments for new product submission strategy. Participate in regulatory agency inspections.
  • Represent Edgewell Personal Care in scientific organizations and workshops, task forces of trade associations, and interactions with global regulatory authorities.

 

Experience/Education Required:

  • Masters with 7 years or Ph.D. Toxicology/Pharmacology 5 years and DABT desired.
  • 10+ years’ experience in Medical Device Industry.
  • Experience within FDA/ EPA risk assessment,  pre-clinical and clinical design at progressively increasing scientific levels.

 

 

Skills and Abilities Required:

  • Excellent verbal / written communication, leadership and interpersonal skills. 
  • Ability to interface with internal and external contacts at all levels. 
  • Project management, critical thinking and problem-solving skills.
  • Good organizational, prioritizing and follow-up skills.  Attention to details.  Ability to handle multiple tasks/projects simultaneously.
  • Ability to work well under pressure, with minimal supervision, and to interact with a variety of contacts, including R&D staff, management, clinical laboratories, consultants, and suppliers.
  • Good computer skills. 

 

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Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.