Head– Regulatory Affairs

Duties & Responsibilities:

Provides regulatory expertise for the site. The incumbent will also be required to provide regulatory
advice and assistance to other Smiths Medical site representatives. Prepare and submit regulatory
submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to
European notified body to support distribution and marketing objectives set.

Ensure regulatory compliance to FDA and international regulations.

Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as
directed.

Create and maintain Essential Requirements Checklists, CE Technical Files, and Declarations of
Conformity for all products bearing the CE Marking.

Prepare Annual PMA Report and associated PMA Supplements as required.

Regulatory representative on new product development teams.

Review and approve ECO's for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance with existing regulatory submissions.

Review and approve technical literature (labelling, IFU’s, manuals, patient guides, etc.), sales and marketing literature, and reimbursement literature related to company products.

Review and approve Pre-launch product submissions to ensure compliance with internal company
requirements and compliance with regulatory requirements.

Review and provide oversight of FDA Drug Listings, State Distributor Licensing among State Boards of Pharmacy, and Global Product Registration in support of Direct Reports.

Keep abreast of new and changing regulatory requirements.

Update RA procedures as needed to ensure Smiths Medical is in compliance with new and changing
regulatory requirements.

Inform project teams of new and changing regulatory requirements.

Assure compliance of company operations to all applicable laws, regulations and standards, good
business practices and company documented procedures (including but not limited to FDA, Quality
Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental
regulations and statutes).

Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement Review and approve engineering change orders (ECO’s) ensuring compliance with FDA and international submissions on file.

Provide regulatory guidance on new product development and manufacturing changes to existing
products.

Review and approve Pre-launch product submissions to ensure compliance with internal company
requirements and compliance with regulatory requirements.

Review and approve product literature to ensure compliance with FDA and international
submissions on file.

Direct the development of international master files for registration of products in international markets.

This position is required to assure compliance of Company operations to all applicable laws,
regulations and standards, good business practices and company documented procedures (including
knowledge of all standards, government occupational health, and environmental regulations and
statutes related to the site).

Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

 

 

 

Technical Knowledge And Skills:

Graduation in any relevant stream.

Minimum of twelve to fifteen years related experience in quality/regulatory affairs (preferably in the medical device or biomedical area).

Excellent working knowledge of up-to-date domestic, international, and company regulatory
compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE,
510(k) Notifications, Medical Device Directive, and European Standards.

Sound knowledge and understanding of how IDE regulated clinical studies are performed.

Knowledge and ability to review and approve ECO's and corporate SOP's.

Sound knowledge and understanding of company products as they relate to medical device law and
international medical device requirements.

Knowledge and ability to develop, review, and approve technical literature as it relates to product specifications and that is consistent with domestic and international regulations.
Effective facilitation skills to motivate engineers, marketing personnel, and/or clinical staff to deliver information related to submission preparation and/or direct product literature review, both technical and sales marketing pieces.

Proven effective leadership skills to guide, mentor, and develop staff members to perform under
stress to meet or exceed project schedules and corporate filing deadlines.

Excellent verbal, written, and presentation communication skills.

 

 

Abilities:
Ability to negotiate critical points regarding devices to the favour of corporate objectives, i.e. to reduce costs associated with regulation and/or marketing objectives

Ability to analytically assimilate regulatory information and updates and effectively convey these principals to appropriate departments.

Ability to develop and implement short and long-range department goals in reference to Regulatory
Affairs.

Ability to influence and lead department members and peers as well as work effectively as a team
player.

Ability to arbitrate conflicts between departments regarding quality and regulatory issues.

Planning And Decision Making Direction is usually stated in general terms of goal or objectives taking several weeks or months to achieve.

Prepares complex regulatory strategies for products the company intends to develop and market.
Develops and implements a plan to improve department efficiency.

Controls/constraints over position are the following current GMP practices employed by the company and company SOP.

Determines if the information contained in ECO is adequate and consistent with domestic and
international submissions.

Develops and/or participates in the development of policies and procedures related to clinical
studies.

The position has great latitude in which to determine the method of preparing product submissions and
applications.

The position has great latitude in methodology on determining how to handle negotiations with the agency staff.

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