Regulatory Affairs Manager Job Description

Regulatory Affairs Manager oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. Being a Regulatory Affairs Manager requires a bachelor’s degree in area of specialty. Typically reports to top management. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. Extensive knowledge of department processes. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required.

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Regulatory Affairs Manager Job Description Template

Our company is looking for a Regulatory Affairs Manager to join our team.

Responsibilities:

  • Provide regulatory input to product lifecycle planning and execution;
  • Providing gap analysis and assessments for change control document activities;
  • Keeping up to date on changes to domestic and international regulations and update submissions to authoritative bodies to ensure compliance;
  • Responsible for inter-departmental compliance with company policies and corrective actions;
  • Manage Canada CEPA Material Surveys;
  • Supports the use of systems, development and maintenance of supporting information related to the use of Regulatory systems;
  • Provides support for tools that manage Registrations, Submissions, Notifications of Change among others;
  • Provides recommendations and support to the Reg Ops team;
  • Approver for invoices, POs, check requests related to FDA, WCS, office supply expenses for BU;
  • Compliance;
  • Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function;
  • Familiar with progress of new and updated regulations that impact the business (regulatory intelligence, coordinated with Global Regulatory);
  • Support the documentation of regulatory strategies;
  • Maintain working knowledge of relevant regulations and requirements that affect the business;
  • Utilize knowledge and experience to identify and tackle problems within the regulatory area.

Requirements:

  • R&D background;
  • B.S. degree in life science or related field;
  • Bachelor’s degree is required, PhD preferred;
  • Bachelor’s Degree with six years of experience in regulatory affairs OR ten years experience in regulatory affairs or regulated industry;
  • Experience in the IVD field preferred;
  • Must be capable of effectively leading teams in preparation of submissions;
  • Ability to work effectively in cross-functional teams;
  • Excellent written and verbal communication skills;
  • Strong Excel skills;
  • You have a passion for healthcare and a knack for making things more systematic;
  • 3+ years’ experience in IVD or Medical Device Regulatory Affairs;
  • Excellent organizational skills and ability to work on a number of projects under tight timelines;
  • Must be capable of reviewing technical documents and influencing colleagues across functions;
  • Ability to operate cross-functionally and chase down answers. You get things done, even when it’s crunch time;
  • Travel up to 10%-20% of the time.