-
Regulatory Affairs Specialist
2 days ago
SeeSpine Montréal, Canada**About us** · We are professional, agile, and innovative. · Our work environment includes: · - Modern office setting · - Food provided · - Modern office setting · - Growth opportunities · - Wellness programs · - Work-from-home days · Job Summary: · We are seeking a highly skille ...
-
Regulatory Affairs Specialist
3 weeks ago
vitaltracer Montréal, CanadaWork Term: Permanent · - Work Language: English · - Hours: 38 to 44 hours per week · - Education: Master's degree · - Experience: 5 years or more · - Bioengineering and biomedical engineering · - Mechanical engineering · **Tasks**: · - Analyze and provide advice on the managerial ...
-
Regulatory Affairs Specialist
1 day ago
Bausch Health Companies Laval, CanadaBausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. · Our team manufactures and markets a wide variety of p ...
-
Specialist Regulatory Affairs
1 week ago
Sobeys Montreal-nord, Canada**Requisition ID**:182413 · **Career Group**:Corporate Office Careers · **Job Category**:Food Safety Regulatory Affairs · **Travel Requirements**:0 - 10% · **Job Type**:Full-Time · **Country**:Canada (CA) · **Province**:Québec · **City**:Montréal · **Location**:Bureau de Montréal ...
-
Regulatory Affairs Specialist
2 days ago
Acclive Inc Dorval, Canada100% Onsite/Extension/FTE: possibility · Top Qualifications: Regulatory and Product Compliance background, Safety/RF knowledge in Information Technology Equipment (ITE), which means computer hardware · this role is to provide Regulatory support for new product development as well ...
-
Specialist Regulatory Affairs
2 weeks ago
Sobeys Montreal, Canada Full timeRequisition ID: 182413 · Career Group: Corporate Office Careers · Job Category: Food Safety Regulatory Affairs · Travel Requirements: 0 - 10% · Job Type: Full-Time · Country: Canada (CA) · Province: Québec · City: Montréal · Location: Bureau de Montréal-Nord · Postal Code: ...
-
Specialist Regulatory Affairs
2 weeks ago
Corporate Office Careers Montreal, Canada Full timePostal Code: · H1G 3J5 Our family of 131,000 employees and franchise affiliates share a collective passion for delivering exceptional shopping experiences and amazing food to all our customers. Our mission is to nurture the things that make life better – great experiences, fami ...
-
Specialist, Commercial Affairs
1 week ago
Duchesnay Blainville, CanadaThis central role contributes to the success of all functions under Commercial Affairs by participating in the development and execution of several key tasks and programs aimed at achieving the objectives of the products under promotion. The position includes an important compone ...
-
Communication Specialist, Corporate Affairs
2 days ago
Sandoz Boucherville, CanadaSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. _ · - Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set c ...
-
Senior Specialist Regulatory Affairs
3 weeks ago
Pharmascience Montréal, QC, Canada: · The Senior Specialist CMC assumes responsibilities to ensure the completeness of CMC documentation for all product dossiers and timely market approvals. He/she will also take part in the evaluation of new opportunities and other cross-functional projects. The ideal candidate ...
-
Regulatory Affairs Sr Specialist
2 weeks ago
Zimmer Biomet Montreal, Canada Full timeAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. · As a Zimmer Biomet team m ...
-
regulatory affairs specialist
2 weeks ago
vitaltracer Côte Saint-Luc, CanadaDurée de l'emploi: Permanent · Langue de travail: Anglais · Heures de travail: 42 to 44 hours per week · Education: · Expérience: · Education · Master's degree · Tasks · Analyze and provide advice on the managerial methods and organization of an establishment · Conduct quality ...
-
regulatory affairs specialist
2 weeks ago
vitaltracer Côte Saint-Luc, CanadaWork Term: Permanent · Work Language: English · Hours: 42 to 44 hours per week · Education: Master's degree · Experience: 5 years or more · Tasks · Analyze and provide advice on the managerial methods and organization of an establishment · Conduct quality audits · Develop qualit ...
-
Pre-Market Regulatory Affairs Specialist
1 week ago
AMD Medicom inc. Outremont, Canada Full timeWhy join our team? · Think you have what it takes to work in an organization where creativity, drive and ambition are valued while integrity motivates everything we do? · Medicom · has been in business for over 35 years, and it has kept its entrepreneurial mindset. Working with u ...
-
Regulatory Affairs Specialist
1 week ago
Bausch Health Companies Laval, QC, CanadaRegulatory Affairs Specialist - CMC in Laval , Quebec · Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians ...
-
Pharmascience Inc. Montréal, QC, CanadaSenior Specialist CMC, Global Regulatory Affairs · Job Category : Regulatory Affairs · Apply now · Posted : April 26, 2024 · Full-Time · Locations · Showing 1 location · Description · The Senior Specialist CMC assumes responsibilities to ensure the completeness of CMC do ...
-
Regulatory Affairs Specialist
3 weeks ago
Bausch & Lomb Laval, CanadaBausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. · Our team manufactures and markets a wide variety of ...
-
Senior Regulatory Affairs Specialist
1 week ago
Bausch Health Laval, QC, CanadaCareer Opportunities: Senior Regulatory Affairs Specialist · Requisition ID Posted - Canada Reg Affairs - R&D - CA - Laval - City (1) · Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical comp ...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Bausch & Lomb Laval, CanadaBausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. · Our team manufactures and markets a wide variety of ...
-
Quality Assurance Specialist
1 week ago
Endocision Technologies Inc. Montréal, Canada**Title**:Regulatory Affairs & Quality Specialist · **Reports to**: Director Regulatory Affairs and Quality Assurance · **Profile**: · The person will be responsible for the management and development of all quality and regulatory duties involving the following: ISO 13485, CE-Mar ...
Regulatory Affairs Sr Specialist - Montreal, Canada - Zimmer Biomet
Description
JOB DESCRIPTIONAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
What You Can Expect
This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.
How You'll Create Impact
Assist with assembly, distribution, storage, tracking, and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions
Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates
Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
Evaluates risk of proposed regulatory strategies and offers solutions
Reviews proposed labeling for compliance with applicable US and international regulations
Writes, manages, and approves the development of package inserts
Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams
Follows Zimmer Biomet regulatory affairs policy and procedures
May provide training and/or guidance to entry-level associates, analysts, interns, and specialists
Communicates with regulatory and governmental agencies
Miscellaneous responsibilities as assigned
What Makes You Stand Out
Demonstrated strong writing and communication skills.
Strong interpersonal skills and attention to detail.
Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities.
Proficient knowledge of overall business environment, the orthopaedic industry, and the marketplace-Mastery of relevant regulations pertinent to medical devices, biologics, drugs, and combination products as applicable
Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization
Able to identify risk in regulatory strategies
Robust product knowledge
Advanced anatomic knowledge-Proven analytical and negotiation skills
Experience with solving problems and concerns-Intermediate computer skills, including Microsoft Office Suite-Ability to lead a team and influence others-Proficient knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU
Your Background
Bachelor's Degree (non-CAN or non-US equivalent) required. Technical/engineering degree, life sciences, or related field preferred. Alternate degrees may be considered.
Advanced degree preferred
A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
A minimum of 2 years of experience in orthopaedic or medical device industry preferred
Regulatory Affairs Certification ( CAN, US or EU) preferred
A combination of education, experience, leadership, strategy, and RA influence may be considered
Travel Expectations
Up to 15%
EOE/M/F/Vet/Disability