Global Regulatory Affairs Manager

24 Apr, 2022

Jobs

Global Regulatory Affairs Manager

Haemonetics
Remote

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

 

 

Job Details

Summary:

This position is responsible for managing sustaining regulatory activities for the Class III vascular closure portfolio (FDA, TGA, EMEA, Japan MHLW/PMDA, etc.).  Key responsibilities include establishment registrations, device listings, periodic reporting, agency correspondence, as well as internal evaluation of changes, participation on cross functional teams for international staged roll-outs of approved changes, as well as interfacing with International In-Country Regulatory Affairs teams.

 

Essential Duties and Responsibilities:

  • Regulatory Strategy

Develop and interpret regulatory requirements from targeted global markets, recommend to Regulatory Affairs Management specific activities and resources required to support and execute strategies to further the global growth of the business.

  • Global Regulatory Listings

Ensure that international submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations .

  • External regulatory databases (e.g. GUDID, EUDAMED, device listings, etc.)
  • Internal regulatory information system (RIMSys)
  • Global regulatory filings, periodic reports, and updates as needed (e.g. annual report, Technical Documentation update)
  • Sustaining Regulatory

Support change management and market expansion for multiple Class III products/product lines including, but not limited to:

  • Regulatory Submissions – Class III implant e.g. FDA PMA supplements, NB significant change notifications, etc.
  • Periodic Product Review Reports;
  • Change Evaluations for design, process and manufacturing changes;
  • Regulatory compliance with FDA, EMEA, TGA, Japan MHLW/PMDA, etc.  and other applicable regional requirements, etc. including, but not limited to:
    • Implement regulatory system changes to support evolving regulations and international standards
    • Product technical documents/files
    • Complaint reviews for reportable events
    • Recall / FSCA / HHE reviews and evaluations
    • CAPA/NCMR team member
    • Management review reporting activities
    • Evaluate and approve product advertising/promotional materials for regulatory compliance
  • This position can be delegated as a Person Responsible for Regulatory Compliance (PRRC) under EU MDR (2017/745) with responsibility for ensuring that:
    • The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
    • The technical documentation and the EU declaration of conformity are drawn up and kept up to date
    • The post-market surveillance obligations are complied with in accordance with the requirement of the MDR
    • Vigilance reporting obligations are fulfilled
    • In the case of investigational devices, ensuring that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject

 

Qualifications:

  • Thorough knowledge of FDA, MDR, and ISO 13485 standards, regulations and requirements and working knowledge of other international regulatory requirements.
  • Course program(s) or advanced training in Regulatory Affairs and/or Clinical Research preferred (RAPS, SOCRA, ASQ, etc.).
  • Strong technical knowledge of medical device products.
  • Multi-lingual a plus.

 

Education and Experience:

  • Minimum 7 years of experience in the medical device industry with previous experience in regulatory and/or quality.
  • Bachelor’s degree in a science or health-based discipline required. Master’s degree a plus.

 

Skills:

  • Must have excellent verbal and interpersonal skills, as well as clear, logical writing ability.
  • Excellent problem-solving and prioritization skills.
  • Ability to craft a narrative that clearly and concisely addresses the questions at hand e.g. FDA interactive review and annual reports, notified body change notifications, CAPAs, etc.
  • Ability to create and execute effective plans to address issues/goals.
  • Evidence-based approach to all activities.
  • Advanced proficiency in Word and Adobe Acrobat required
  • Excel proficiency inclusive of pivot tables and formulas (macros/programming not required)

 

Physical Demands:

  • None

 

Work Environment:

  • Office environment
  • Occasional domestic and international travel

 

 

EEO Policy Statement

 

Conditions of Employment: Haemonetics’ policy requires COVID-19 vaccination for all U.S. employees, unless approved for a medical, religious or business exemption. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, our customers and our communities as we continue to make health and safety our top priority.

Learn more here

Job posted: 2022-04-24